- 26
- July
- 26
- Friday
Human Error Risk Management In Medical Device Design
The topic delves into the critical interplay between human factors, design processes, and patient safety within the realm of healthcare technology. It begins by elucidating the multifaceted nature of human errors, encompassing cognitive, perceptual, and physical aspects, and underscores their potential impact on patient well-being.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- July
- 26
- Friday
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.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- July
- 26
- Friday
Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- July
- 26
- Friday
6-Hour Virtual Seminar on GCP/GLP/GMP: Comparison and Understanding of the FDA's 3 Major Regulations
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
John E Lincoln |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 29
- July
- 29
- Monday
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 29
- July
- 29
- Monday
FDA Best Audit 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
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 29
- July
- 29
- Monday
Building GMP Excellence: A Guide to Implementing Compliant Training Programs
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- July
- 30
- Tuesday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- July
- 30
- Tuesday
Understand the Different Contexts in DAX, The Filter Context vs The Row Context in DAX
Unlock the full potential of your data with our upcoming seminar on understanding row context versus filter context in DAX, tailored for Power BI users.
Abdelrahman Abdou |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- July
- 30
- Tuesday
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 |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 31
- July
- 31
- Wednesday
Post-Market Surveillance And Project Management Ensuring Long-term Success
This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 31
- July
- 31
- Wednesday
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 |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 31
- July
- 31
- Wednesday
The Most Common FDA Observations and Prevention Strategies
In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success.
Meredith Crabtree |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 31
- July
- 31
- Wednesday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 1
- August
- 01
- Thursday
Developing a Strategic Approach to FDA Compliance for Validation of Computer Systems
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 1
- August
- 01
- Thursday
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 |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 2
- August
- 02
- Friday
6-Hour Virtual Seminar on FDA Audit Preparation
This seminar is broken into two phases. Phase one will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 2
- August
- 02
- Friday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft 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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 2
- August
- 02
- Friday
The Human Error Toolbox: 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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 2
- August
- 02
- Friday
Excel & ChatGPT Synergy Masterclass: Unleashing Financial Analysis Superpowers
In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.
Garrett Wasny |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 5
- August
- 05
- Monday
PowerPoint Creating & Presenting a Complete Slide Show
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 5
- August
- 05
- Monday
Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Michael Esposito |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 5
- August
- 05
- Monday
Introduction to Generative AI for Accountants
This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.
Garrett Wasny |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 5
- August
- 05
- Monday
Excel - Quick Tips to Help You Be More Productive
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- August
- 06
- Tuesday
What If Analysis Tools in Excel: Goal Seek, Solver, and Data table
Attending this webinar will equip you with practical skills to leverage Excel's powerful What If Analysis tools Goal Seek, Solver, and Data Table.
Abdelrahman Abdou |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 6
- August
- 06
- Tuesday
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.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- August
- 06
- Tuesday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- August
- 06
- Tuesday
SOPs - How to Write Them to Satisfy Those Inspectors
Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.
Meredith Crabtree |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 6
- August
- 06
- Tuesday
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.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- August
- 06
- Tuesday
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 |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 7
- August
- 07
- Wednesday
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 7
- August
- 07
- Wednesday
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
David Nettleton |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 7
- August
- 07
- Wednesday
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 7
- August
- 07
- Wednesday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 7
- August
- 07
- Wednesday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.
David Nettleton |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
- 9
- August
- 09
- Friday
The World of Global Cash Flow: Is There Enough to Cover All Debts?
Global cash flow is critical to analyzing and underwriting commercial borrowers, especially smaller, privately held firms where the owners and the company are so closely bound together that their assets, liabilities, and income are comingled.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 9
- August
- 09
- Friday
4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Tom Fragale |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 9
- August
- 09
- Friday
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 12
- August
- 12
- Monday
Quality Management 101: An Enterprise Maintenance Professional's Guide
What are the basics of an enterprise maintenance-focused Quality Management System?
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 12
- August
- 12
- Monday
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 12
- August
- 12
- Monday
6-Hour Virtual Seminar on Project Management within the Life Sciences
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 13
- August
- 13
- Tuesday
Using Images in Pivot tables for Better Data Visualization
Are you looking to elevate your Excel skills and create more engaging and visually appealing reports?
Abdelrahman Abdou |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 13
- August
- 13
- Tuesday
The Income Statement - What a Banker can Learn About a Borrower from Its Profit and Loss Statement
This program is designed to assist bankers, lenders, and credit professionals who want a fundamental understanding of the information that is contained in the income statement.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 13
- August
- 13
- Tuesday
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. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 13
- August
- 13
- Tuesday
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.
Carolyn Troiano |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 13
- August
- 13
- Tuesday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 14
- August
- 14
- Wednesday
Quality Management 101: Enterprise Maintenance Professional's Guide
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 14
- August
- 14
- Wednesday
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 14
- August
- 14
- Wednesday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 14
- August
- 14
- Wednesday
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 |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 15
- August
- 15
- Thursday
Controlling Human Error in the Manufacturing Floor
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 15
- August
- 15
- Thursday
FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions
Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 15
- August
- 15
- Thursday
Excel - Essential Tips and Tricks for the New User
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- August
- 16
- Friday
6-Hour Virtual Seminar on Project Management for Non-Project Managers
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 16
- August
- 16
- Friday
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- August
- 16
- Friday
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 |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 19
- August
- 19
- Monday
ChatGPT and Complex Financial and HR Conversations for Accountants
The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.
Garrett Wasny |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 19
- August
- 19
- Monday
Excel - A Beginner's Guide to Formulas
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 19
- August
- 19
- Monday
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.
Tom Fragale |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 20
- August
- 20
- Tuesday
QMS 101: Quality Management System Guide
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 20
- August
- 20
- Tuesday
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)
Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 20
- August
- 20
- Tuesday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 20
- August
- 20
- Tuesday
New Regular Expressions (REGEX) functions in Excel
As the volume of data we handle continues to grow exponentially, the ability to efficiently process and analyze text data becomes increasingly crucial.
Abdelrahman Abdou |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
- 21
- August
- 21
- Wednesday
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 21
- August
- 21
- Wednesday
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 21
- August
- 21
- Wednesday
Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Meredith Crabtree |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 21
- August
- 21
- Wednesday
Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 21
- August
- 21
- Wednesday
Strategies to Prevent Manufacture and Distribution of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 21
- August
- 21
- Wednesday
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Robert J. Russell |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 22
- August
- 22
- Thursday
ChatGPT for Excel
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- August
- 22
- Thursday
2-Hour Virtual Seminar on Reduce Performance Failures in Your Operations by Addressing Human Performance, Human Error, and Cognitive Effort
In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.
Charles H. Paul |
Duration: 2 Hours |
Price: ¤199.00
| View Details
- 22
- August
- 22
- Thursday
The Credit Manager's Toolbox - Tools and Techniques for Making Sound Credit Decisions
This webinar will provide guidance on how gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- August
- 22
- Thursday
ChatGPT for Innovative Business Advisory Services for Accountants
The course provides a concise overview of how accounting professionals can leverage ChatGPT, OpenAI's powerful language model, to innovate and enhance their business advisory services. In plain language the presentation integrates theory and practice, and demonstrates how various enterprise evaluation methodologies can be applied in combination with ChatGPT to sharpen your business analysis and increase your organization’s efficiency, profitability, and growth
Garrett Wasny |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 23
- August
- 23
- Friday
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 |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 26
- August
- 26
- Monday
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.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- August
- 26
- Monday
ChatGPT & AI for Project Management for FDA-Regulated Companies
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 27
- August
- 27
- Tuesday
Cash Flow Projections for Long-term Lending
Financial organization extend credit to borrowers when the borrowers show the ability to repay the loans extended.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 27
- August
- 27
- Tuesday
Excel - Mastering Lookup Functions
"How do I look up a value in list ONE and pick up a related value from list TWO"
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 27
- August
- 27
- Tuesday
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 |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 28
- August
- 28
- Wednesday
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.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 28
- August
- 28
- Wednesday
How to Deal with Bad Results Under GLP
Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 28
- August
- 28
- Wednesday
Using a Learning Management System (LMS) to Develop Pharma Training Curricula
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 29
- August
- 29
- Thursday
How to Write SOPs for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 29
- August
- 29
- Thursday
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 29
- August
- 29
- Thursday
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- August
- 30
- Friday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- August
- 30
- Friday
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 30
- August
- 30
- Friday
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 |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- August
- 30
- Friday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 2
- September
- 02
- Monday
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 |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 3
- September
- 03
- Tuesday
Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Michael Esposito |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 3
- September
- 03
- Tuesday
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.
John E Lincoln |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 4
- September
- 04
- Wednesday
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.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 4
- September
- 04
- Wednesday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft 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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 4
- September
- 04
- Wednesday
Excel - Quick Tips to Help You be More Productive
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 4
- September
- 04
- Wednesday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 5
- September
- 05
- Thursday
GAMP®5, 2nd Edition & Alignment with FDA's Draft Guidance for Computer Software Assurance(CSA)
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 5
- September
- 05
- Thursday
How to Write SOPs that Avoid Human Error
Human error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 5
- September
- 05
- Thursday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- September
- 06
- Friday
ChatGPT for Excel
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- September
- 06
- Friday
6-Hour Virtual Seminar on FDA Audit Preparation, Inspection Conduct, and Do's and Don'ts
This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 6
- September
- 06
- Friday
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).
Robert J. Russell |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 9
- September
- 09
- Monday
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 9
- September
- 09
- Monday
6-Hour Virtual Seminar on Strategic Risk Management for Medical Device Design Excellence
The 6-Hour seminar provided a comprehensive exploration of the medical device design and development process with a primary focus on the crucial aspect of risk management. In the introduction, participants gained an overview of the entire medical device design and development process, emphasizing the paramount importance of integrating effective risk management strategies.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 9
- September
- 09
- Monday
Quality Management Do's and Don't's
ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 9
- September
- 09
- Monday
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 10
- September
- 10
- Tuesday
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. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 11
- September
- 11
- Wednesday
The Human Error Toolbox: 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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 11
- September
- 11
- Wednesday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.
David Nettleton |
Duration: 75 Minutes |
Price: ¤150.00
| View Details
- 11
- September
- 11
- Wednesday
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 11
- September
- 11
- Wednesday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 11
- September
- 11
- Wednesday
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 |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 11
- September
- 11
- Wednesday
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.
David Nettleton |
Duration: 2 Hours |
Price: ¤199.00
| View Details
- 12
- September
- 12
- Thursday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 13
- September
- 13
- Friday
Trial Master File (TMF)/eTMF, & FDA's Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 13
- September
- 13
- Friday
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- September
- 16
- Monday
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 16
- September
- 16
- Monday
Excel - Essential Tips and Tricks for the New User
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Tuesday
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Tuesday
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 |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Tuesday
Building GMP Excellence: A Guide to Implementing Compliant Training Programs
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 17 & 18
- September
- 17
- Tuesday
2-Day Virtual Seminar on Project Management for Non-Project Managers - PM in the Life Sciences - Pharmaceutical/ Biotechnology and Medical Devices
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Charles H. Paul |
Duration: 2 Days |
Price: ¤995.00
| View Details
- 18
- September
- 18
- Wednesday
6-Hour Virtual Seminar on Successfully Preparing for, Conducting, and Executing an FDA Audit of your Operations
This seminar is broken into two phases. Phase One corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 18
- September
- 18
- Wednesday
Understanding How Quality Management Works
What are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 18
- September
- 18
- Wednesday
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Robert J. Russell |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 18
- September
- 18
- Wednesday
Excel - A Beginner's Guide to Formulas
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 19
- September
- 19
- Thursday
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 20
- September
- 20
- Friday
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance
So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 23
- September
- 23
- Monday
3-Hour Virtual Seminar on Bootcamp on Quality Management System (QMS)?
What are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.
John E Lincoln |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 23
- September
- 23
- Monday
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 |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 23
- September
- 23
- Monday
Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Tuesday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Tuesday
Using a Learning Management System (LMS) to Develop Pharma Training Curricula
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 25
- September
- 25
- Wednesday
How to Deal with Bad Results Under GLP
Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 25
- September
- 25
- Wednesday
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.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 25
- September
- 25
- Wednesday
The Human Error Toolbox: 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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 25
- September
- 25
- Wednesday
Excel - Mastering Lookup Functions
"How do I look up a value in list ONE and pick up a related value from list TWO"
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26 & 27
- September
- 26
- Thursday
2-Day Virtual Seminar on Effective Technical Writing in the Life Sciences
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Charles H. Paul |
Duration: 2 Days |
Price: ¤995.00
| View Details
- 26
- September
- 26
- Thursday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 27
- September
- 27
- Friday
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 27
- September
- 27
- Friday
Quality Management 101: An Enterprise Maintenance Professional's Guide
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Monday
Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Monday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft 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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 3
- October
- 03
- Thursday
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU).
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 8 & 9
- October
- 08
- Tuesday
2-Day Virtual Seminar on Technical Writing in the Life Sciences - Writing Regulatory Documentation for Consistency, Clarity, Accuracy, and Utility
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Charles H. Paul |
Duration: 2 Days |
Price: ¤995.00
| View Details
- 10
- October
- 10
- Thursday
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 17
- October
- 17
- Thursday
Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 24
- October
- 24
- Thursday
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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