Gina Reo

Developing a Food Safety Culture For FSMA

Instilling a passion with team members to create a Right Time Culture for Quality and Food Safety ensures wholesome products everyone can enjoy. This process begins with a plan aligned with FSMA, a Food Safety Roadmap, that starts at the design stage, through production, monitoring, and finally when the customer or consumer indulges in the vast array of today’s convenient food products available globally.

Speaker: Gina Reo | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

Cash Flow Analysis Of Borrower's Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

The Credit Manager's Tool Box - Tools And Techniques For Making Sound Credit Decisions

This webinar will provide guidance on how to gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers You will also learn the differences between unaudited and audited financials and how to use and interpret financial ratios in your analysis. You will also learn how to write a simple but thorough credit proposal.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

Key Elements in Managing and Maintaining Your Credit Administration and Credit Policy

This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank. The session also highlights the safeguards to manage the bank’s loan portfolio in a safe and sound manner.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

C for Yourself: The 5 C's of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

4-Hour Virtual Seminar on Credit Risk Management - Principles and Practices, Tools and Techniques

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.

Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Dev Strischek

4-Hour Virtual Seminar on How to Write Better Communications and Emails

Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.

Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Dev Strischek

4-Hour Virtual Seminar on How to Evaluate Borrower Operating Performance and Financial Condition

This program is designed to show bankers, lenders, and credit professionals how to evaluate a borrower's operating performance and financial condition. Good operating performance and a sound financial condition are critical to a borrower being able to generate sufficient cash flow from operations to repay its debt.

Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Robert J Russell

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Speaker: Robert J Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Robert J Russell

4-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Speaker: Robert J Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Casper Uldriks

4-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Speaker: Casper Uldriks | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Elaine Eisenbeisz

6-Hour Virtual Seminar on Statistics for Process Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Joy McElroy

4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

The objective of this seminar is to compare and contrast between Good Laboratory Practices and Good Manufacturing Practices.

Speaker: Joy McElroy | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Dennis Taylor

4-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Elaine Eisenbeisz

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.

Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Michael Esposito

4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

How to write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

FDA's New Import Program for 2020 and Impact of the COVID-19

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John C Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

The Transfer Of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel Pivot Tables , Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Karla Brandau

Use Microsoft Outlook to Its Fullest Extent: Tips, Techniques and Best Practices. It’s Money in Your Pocket!

Microsoft Outlook is a powerful productivity tool and if you are using it only for email and for keeping track of meetings and appointments, about 80-85% of the power of Outlook is unused. You paid a great deal for the privilege of using Microsoft Outlook - why not wring every dollar you can out of it?

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Karla Brandau

Unmanageable Inbox? Imagine a Clean Inbox and Take Control Today!

Do you remember when hand-written letters or typed letters was the main means of communication? If so, you may also remember how glorious it was to send information and have immediately received via the fax machine.

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Karla Brandau

Learn to Sort, Prioritize and Get Work done Right in your Inbox (Outlook 2013, 2016 & 2019)

Prioritizing is a fundamental time management principle and, in this webinar, you are taught the principles of prioritizing and how to work check off work right in your Inbox.

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Teri C Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Teri C Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Speaker: Teri C Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gina Reo

Food Supplier Auditing Plan, Post-COVID

You deal with hundreds of suppliers. And you need to make sure each and every one of them meets regulations and quality standards. How can you keep your eye on that many suppliers?

Speaker: Gina Reo | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand and engaging.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Gina Reo

4-Hour Virtual Seminar on Lessons Learned from the History of Pandemics Impacting the Food Industry, Implementing a Risk-Based Plan with Next Steps for Industry After COVID-19

There is a broad need to understand the impact of global outbreaks on the food industry. Understanding the potential for pandemics will be detailed, along with historical dive into past episodes in the food industry. Drilling more deeply into nuances of the COVID-19 will also be explored for the application of best practices and early frustrations of the impact of pushing organizations beyond their comfort zones.

Speaker: Gina Reo | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - Determining the Work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.

Speaker: Charles H Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Robert J Russell

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Speaker: Robert J Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Robert J Russell

4-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Speaker: Robert J Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Speaker - OnlineComplianceExperts

4-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries.

Speaker: Eleonora Babayants | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Casper Uldriks

4-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Speaker: Casper Uldriks | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Edwin Waldbusser

Medical Device Cybersecurity following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant with the FDA requirements.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Risk based Computer System Validation

FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment using real-world data to improve performance. Thus the field version of the software is no longer the validated approved version.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John C Fetzer

The Transfer Of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel Pivot Tables , Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Roger Cowan

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification

In this seminar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.

Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Yuval Shapiro

ISO13485: 2016 - Quality Management Systems for Medical Devices

This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.

Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Yuval Shapiro

Cost of Quality from Theory to Implementation

How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Michael Esposito

4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
John E Lincoln

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Elaine Eisenbeisz

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.

Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Dennis Taylor

4-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Speaker: Dennis Taylor | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Carolyn Troiano

4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Gwendolyn Wise Blackman

3-Hour Virtual Seminar on Bioanalytical Method Validation

The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.

Speaker: Gwendolyn Wise Blackman | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Gwendolyn Wise Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Speaker: Gwendolyn Wise Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Gwendolyn Wise Blackman

Implementing Process Controls for Cell-Based Assays

Bioassays are used to demonstrate that a biological product performs per the stated function and potency.

Speaker: Gwendolyn Wise Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Charles H Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Charles H Paul

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Michael Esposito

6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Elaine Eisenbeisz

6-Hour Virtual Seminar on Statistics for Process Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

C for Yourself: The 5 C's of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dev Strischek

4-Hour Virtual Seminar on How to Write Better Communications and Emails

Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.

Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Carolyn Troiano

Medical Device Cybersecurity and FDA Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John C Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification

In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.

Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Teri C Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Teri C Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Speaker: Teri C Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel Pivot Tables , Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Mike Thomas

Excel Data Visualization - Charts and Infographics

In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Casper Uldriks

FDA's New Import Program for 2022 and Impact of the COVID-19

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.

Speaker: Charles H Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - How to effectively monitor and control your project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Speaker: Charles H Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - Forming, developing, and managing your project team

The subject of this webinar is building the project team.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - Determining the work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers - How to communicate project actions and progress - conducting effective project review meetings

This webinar is about effective communication inside and outside of the project team.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Jeff Kasoff

FDA Inspections - Do's and Don'ts

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

6-Hour Virtual Seminar on Bootcamp on Excel

In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Charles H Paul

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Casper Uldriks

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Karla Brandau

2-Hour Virtual Seminar on Microsoft Outlook on Steroids

The first step in catapulting your career ahead of your competitors is fully to use Microsoft Outlook.

Speaker: Karla Brandau | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Brodsky

ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again

Many laboratories have successfully developed and implemented a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.

Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Speaker - OnlineComplianceExperts

FDA Compliance for Mobile Applications

Attend this webinar to understand the FDA guidance for mobile applications.

Speaker: Eleonora Babayants | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Edwin Waldbusser

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Medical Device Complaints & CAPA

This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Carolyn Troiano

Medical Device Software Cybersecurity and IEC 62304 Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Carolyn Troiano

Medical Device Cybersecurity and FDA Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

How to write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John C Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

The Transfer Of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C Fetzer

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Speaker: John C Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Teri C Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Speaker: Teri C Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Charles H Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Casper Uldriks

FDA's New Import Program for 2022 and Impact of the COVID-19

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gwendolyn Wise Blackman

3-Hour Virtual Seminar on Bioanalytical Method Validation

The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.

Speaker: Gwendolyn Wise Blackman | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Gwendolyn Wise Blackman

Auditing Laboratories Conducting Assays Supporting Biologics

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.

Speaker: Gwendolyn Wise Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Gina Reo

Food Supplier Auditing: A Four-Part Plan, Post-COVID

You deal with hundreds of suppliers. And you need to make sure each and every one of them meet regulations and quality standards. How can you keep your eye on that many suppliers?

Speaker: Gina Reo | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Brenda Neckvatal

Mandating COVID Vaccines at Work

The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.

Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Charles H Paul

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Device

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Charles H Paul

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Speaker: Charles H Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.

Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Jeff Kasoff

FDA Inspections - Do's and Don'ts

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Danielle DeLucy

6-Hour Virtual Seminar - Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.

Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Medical Device Complaints & CAPA

This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Carolyn Troiano

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Ginette Collazo

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Teri C Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Speaker: Teri C Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tom Fragale

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.

Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Robert J Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Speaker: Robert J Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Brenda Neckvatal

Mandating COVID Vaccines at Work

The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.

Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $199.00 | View Details
Steven Walfish

Test Regulatory Challenges of Real-world Artificial Intelligence

This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.

Speaker: Steven Walfish | View Anytime | Duration: 60 Minutes | Price: $100.00 | View Details
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