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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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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.
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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