The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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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. 27, 2021
Description: FDA submissions expert Judity Meritz outlines the key information needed for an FDA emergency use authorization (EUA) application for a medical device. She discusses:
- The scope of an EUA;
- What the FDA looks for in the crucial risk-benefit section;
- How the EUA’s criteria for safety, performance and labeling differ from the FDA’s regular medical device clearance and approval process; and
- The FDA’s thought process — and concerns raised — in recent EUA submissions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Judith Meritz, Partner, Meritz & Muenz
Recorded on: Jan. 27, 2021
Description: China regulatory expert Grace Fu Palma discusses the China National Medical Products Administrations developing clinical trial regulations. She covers:
- Different clinical pathways and how to decide which pathway to choose;
- Key areas you need to pay focus on to shorten clinical trials and approval times;
- Whether your devices qualify for the real-world data/study Hainan program and how to get into the program; and
- Key considerations on the feasibility and justification of overseas clinical data acceptance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Grace Fu Palma, CEO, China Med Device
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
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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