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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
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If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.
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Webinar Training Pass
Recorded on: Jan. 26, 2021
Description: A panel of experts discusses using technology to increase study startup speed. They cover:
- Standardizing processes across multiple sponsors;
- Market dynamics and industry solutions; and
- Leveraging data for full study optimization.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Sujay Jadhav, Global Vice President, Oracle Health; Larissa Comis, Product Lead, Cognizant Healthcare and Life Sciences; David Morin, Director of Research, Holston Medical Group; Jimmy Bechtel, Vice President, Society of Clinical Research Sites; Patricia Lorusso, Professor of Medical Oncology, Yale School of Medicine
Recorded on: Jan. 21, 2021
Description: Regulatory expert Christy Coleman shares how virtual MDSAP audits are being conducted and what you must do to ensure effective ones. She discusses:
- Real-world examples of remote MDSAP audit experience;
- Best practices for managing remote MDSAP audits;
- Virtual MDSAP audit challenges and how to mitigate them, including issues with video conferencing and file-sharing technologies; and
- Alternatives when technology does not work as expected.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Christy Coleman, Vice President of Regulatory, Irrimax
Recorded on: Jan. 19, 2021
Description: Risk management expert Amanda McFarland discusses applying risk-based decisionmaking to ensure the long-term impacts of your company’s current decisions are fully understood. She covers:
- Ways to integrate quality risk management (QRM) into your quality systems, such as change control and investigations, and how integration can benefit your organization;
- Risk management tools available to you to meet regulatory requirements, such as process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP), and FMEA; and
- Recognizing the critical QRM regulations that apply to pharma, such as ICH 9, ICH Q10, ISO 14644 and Annex 1.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Amanda McFarland, QRM and Microbiology Senior Consultant, ValSource
Recorded on: Jan. 14, 2021
Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:
- FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
- How to determine spreadsheet validation gaps the FDA targets;
- How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
- How to plan, manage and resource an effective project.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance
Recorded on: Jan. 13, 2021
Description: Industrial-organizational psychologist Ginette Collazo explains how to write SOPs that minimize human error. She discusses:
- How to prepare an outline and develop world-class SOPs;
- The interrelationship between SOPs, quality and regulatory compliance;
- How to create and maintain a procedure that minimizes human error; and
- Use of electronic information networks for procedural access.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ginette Collazo, CEO, Human Error Solutions
Recorded on: Dec. 17, 2020
Description: Quality systems expert Dan O’Leary presents methods for reporting adverse events in both the U.S. and the EU. He discusses:
- Key requirements in adverse event reporting to regulators in the U.S. and the EU;
- Important differences between reporting systems in both regions;
- Recent changes in the adverse event reporting forms in the U.S. and the EU; and
- Comparisons of the content expectations in the forms for both systems.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O'Leary, President, Ombu Enterprise
Recorded on: Dec. 17, 2020
Description: A panel of experts discusses how modern cloud solutions enable organizations to increase the speed and accuracy of virtual audits. Topics include:
- How the pandemic and remote working have impacted the life sciences industry;
- The best practices of conducting remote audits;
- Real-world examples of using cloud QMS to improve audit responsiveness in virtual environments; and
- How a unified quality environment drives audit and inspection readiness.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Snehal Srikrishna, Senior Director of Strategy and Mike Kawano, Director, Vault Quality, Veeva Systems; Ralph Mazenko, Executive Director Clinical QA, Merck; Marcus Massingham, Senior Director, Quality Systems, GlaxoSmithKline
Recorded on: Dec. 16, 2020
Description: Regulatory compliance expert Steven Lynn shares the basics of the COVID-affected supplier relationship, emphasizing the best practices you must incorporate to manage it over time. He discusses:
- How to structure a pharmaceutical supplier agreement that incorporates specific clauses to assist you in monitoring your supplier during the pandemic;
- How to use new technology to develop best practices for monitoring and overseeing your supplier partnerships; and
- How to conduct world-class supplier audits during the pandemic.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Lynn, Executive Vice President of Pharmaceuticals, Regulatory Compliance Associates
Drug, Biologics and Combination Products Labeling: Complying with FDA's Most Recent Guidance
58 minutes
Recorded on: Dec. 8, 2020
Description: Food and drug attorney Alan Minsk discusses the FDA’s new labeling guidance on instructions for use (IFU). He covers:
- The kind of language IFUs should be written in to be patient friendly;
- What the guidance recommends in terms of voice, commands and sentences;
- Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal; and
- Recommendations the FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Alan Minsk, Partner, Arnall Golden Gregory
Recorded on: Dec. 3, 2020
Description: Validation expert Tim Fischer discusses the FDA’s new Computer System Assurance (CSA) and its focus on quality risk management. He covers:
- Critical risk thinking;
- Computer systems to which CSA applies;
- Performance metrics needed; and
- Transition and next steps.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Great Solutions
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