• 12
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • August
  • 2022
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

Michael Esposito Michael Esposito | Duration: 4 Hours | Price: $445.00 | View Details
  • 16
  • August
  • 2022
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 16
  • August
  • 2022
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H Paul Charles H Paul | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • August
  • 2022
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

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.

John C Fetzer John C Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $299.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
08:30 AM PDT | 11:30 AM EDT

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.

Gwendolyn Wise Blackman Gwendolyn Wise Blackman | Duration: 3 Hours | Price: $299.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 17
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

CAPA: Corrective and Preventative Actions and Non-Conformances

If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • August
  • 2022
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-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.

Dennis Taylor Dennis Taylor | Duration: 6 Hours | Price: $545.00 | View Details
  • 18
  • August
  • 2022
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 18
  • August
  • 2022
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J Russell Robert J Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • August
  • 2022
  • Friday
08:00 AM PDT | 11:00 AM EDT

6-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.

Robert J Russell Robert J Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 19
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • August
  • 2022
  • Friday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Susanne Manz Susanne Manz | Duration: 6 Hours | Price: $545.00 | View Details
  • 19
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
  • 22
  • August
  • 2022
  • Monday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 23
  • August
  • 2022
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

Charles H Paul Charles H Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 23
  • August
  • 2022
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 24
  • August
  • 2022
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 24
  • August
  • 2022
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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.

Dev Strischek Dev Strischek | Duration: 4 Hours | Price: $445.00 | View Details
  • 24
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • August
  • 2022
  • Thursday
08:00 AM PDT | 11:00 AM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 25
  • August
  • 2022
  • Thursday
08:00 AM PDT | 11:00 AM EDT

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.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 25
  • August
  • 2022
  • Thursday
08:00 AM PDT | 11:00 AM EDT

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.

Tom Fragale Tom Fragale | Duration: 6 Hours | Price: $545.00 | View Details
  • 25
  • August
  • 2022
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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).

Casper Uldriks Casper Uldriks | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • August
  • 2022
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • August
  • 2022
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Verification or Validation of Methods in Food Microbiology

Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • August
  • 2022
  • Friday
08:00 AM PDT | 11:00 AM EDT

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.

Charles H Paul Charles H Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 26
  • August
  • 2022
  • Friday
08:00 AM PDT | 11:00 AM EDT

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.

Joy McElroy Joy McElroy | Duration: 4 Hours | Price: $445.00 | View Details
  • 26
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H Paul Charles H Paul | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • August
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • August
  • 2022
  • Monday
08:00 AM PDT | 11:00 AM EDT

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.

Robert J Russell Robert J Russell | Duration: 4 Hours | Price: $445.00 | View Details
  • 29
  • August
  • 2022
  • Monday
10:00 AM PDT | 01:00 PM EDT

Writing Excellent SOPs

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

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • August
  • 2022
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • August
  • 2022
  • Monday
10:00 AM PDT | 01:00 PM EDT

Excel: Tips and Tricks and Shortcuts

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

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 30
  • August
  • 2022
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

Danielle DeLucy Danielle DeLucy | Duration: 6 Hours | Price: $545.00 | View Details
  • 30
  • August
  • 2022
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 30
  • August
  • 2022
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J Russell Robert J Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • August
  • 2022
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

This seminar will examine the existing requirements for theUS FDA's DHF including its derivative documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and its Technical Documentation File requirements, and evaluate the documents' differing purposes/goals.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 30
  • August
  • 2022
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on Effective CAPA within a Device Quality System

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 31
  • August
  • 2022
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)

This seminar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

Joy McElroy Joy McElroy | Duration: 6 Hours | Price: $545.00 | View Details
  • 31
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John C Fetzer John C Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 31
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • August
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • September
  • 2022
  • Friday
10:00 AM PDT | 01:00 PM EDT

Latest HIPAA Rulings and Guidance for 2022

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 14
  • September
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • September
  • 2022
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • September
  • 2022
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
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