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: July 12, 2023
Description: Jim Polarine, a senior technical service manager at STERIS Corporation, offers a comprehensive action plan for designing a holistic cleaning and disinfection program, including:
- Cleaning and disinfection best practices;
- The latest advancements in application equipment and methods of cleaning;
- A comprehensive understanding of how to develop a holistic contamination; and control strategy that includes an effective risk-based cleaning and disinfection program.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation
Recorded on: June 22, 2023
Description: Life sciences training experts discuss leveraging and incorporating the latest trends and innovations to enhance your learning programs and drive business success, including:
- The emerging trends in training and development in life sciences;
- Best practices for considering new technologies or modalities for your training programs; and
- Tips for measuring the effectiveness of your training programs.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Christian Torstensson, Director of Learning and Development, Sanofi; Kari Borroel, MBA, Head of Operations Quality Learning & Development and Operations GxP Learning, AstraZeneca/Alexion Rare Disease; John Constantine, SVP, Orchestrall Inc.; and Kent Malmros, VP, Training Strategy, Veeva Systems
Recorded on: June 20, 2023
Description: Gain a thorough understanding of the framework needed to streamline GxP computer platform implementations and their ongoing lifecycles, including:
- How to identity the intended use;
- How to determine the best risk-based approach;
- How to determine the appropriate level of assurance activities; and
- How to establish the appropriate record.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Principal Partner, Great Solutions, LLC
Recorded on: June 14, 2023
Description: Amanda McFarland explains how to apply the principles of QRM to achieve compliance, revealing:
- The changes in ICH Q9(R1);
- Best practices related to QRM program development and execution, including process, people and documentation;
- Methods to, and the benefits of, integrating QRM into your quality systems, such as change control and investigations; and
- How QRM can strengthen your contamination control strategy.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Amanda McFarland, Senior QRM and Microbiology Consultant, ValSource
Recorded on: June 13, 2023
Description: In this presentation, you’ll learn the details of the quality management digital maturity model and where your peers in the life sciences rank on the quality digital maturity spectrum. You’ll also learn:
- What the quality management maturity model is and how it helps you measure your digital progress;
- What keeps companies from digitally progressing and how to overcome those barriers;
- How the life sciences industry is currently distributed across the digital maturity model; and
- Where the industry is headed and how you can stay ahead of competitors.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Marty Smyth, Senior Vice President of Go-To-Market Strategy, MasterControl; and Jessica Madsen, Senior Product Marketing Manager, MasterControl
Recorded on: June 6, 2023
Description: This webinar helps you understand and comply with the FDA’s requirements and avoid common errors so you can maintain your products’ critical quality attributes (CQAs) and bring them to market. You’ll learn:
- FDA requirements for comparability studies for gene and cell therapy products;
- Best practices for risk analysis and mitigation using comparability studies;
- How to design an effective comparability protocol for a gene or cell therapy product; and
- How to construct a statistical approach to comparability.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy; and William E. Janssen, PhD, Principal, WEJ Cell and Gene Therapy Consulting Services
Recorded on: May 25, 2023
Description: Mike Farrell, IT Manager at Illumina, explains how their supplier portal tracks supplier performance, actionable data and empowers suppliers in audits, corrective actions and other critical quality processes. He explains:
- Why Illumina moved away from inefficient, manual supplier processes;
- The benefits of getting the right supplier data at the right time to drive continuous improvement;
- How to drive supplier adoption of a QMS; and
- Best practices and lessons learned when it comes to supplier management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mike Farrell, IT Manager, Illumina
Recorded on: May 17, 2023
Description: This webinar provides a refresher of the current regulatory landscape around IVDs and LDTs and how the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) could change it. You will learn about the:
- Current CLIA framework and LDTs
- FDA regulation of IVD tests as medical devices and their regulatory stance towards LDTs
- History and development of the VALID Act and the framework to define and regulate in vitro clinical tests (IVCT)
- Legislative pathways and prospects for the VALID Act to become law and FDA implementation timelines
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael M. Gaba, FDA Practice Vice Chair, Polsinelli; Colleen Faddick, Health Care Operations Practice Chair, Polsinelli; and Christopher C. Rorick, Senior Policy Advisor, Public Policy Practice Group, Polsinelli
Recorded on: May 11, 2023
Description: Andrew Mackinnon, Martha LaManna, and Mel Mann, discuss the benefits of modern clinical trials that help pharma sponsors and CROs demonstrate greater collaboration, appreciation, and understanding for the roles of patients and sites. They cover:
- Strategies for building empathy and human interaction into the digitized trial process;
- The importance of how best to listen to sites and build trusting relationships;
- How to ease the implementation of clinical trial technology and demonstrate why growing pains are normal during digital change; and
- Best practices from other industries that have successfully gone digital and how the clinical trial industry is headed in the right direction.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Andrew Mackinnon, VP and GM eConsent, Medable; Martia LaManna, Director of Customer Success, Innovative Supply Solutions; and Mel Mann, MBA, M.Ed., Patient Advocate & Advisor, Be The Match
Recorded on: May 10, 2023
Description: FDA regulatory experts Kristin Zielinski Duggan and Sally Gu dig into the FDA’s guidance around RWE as support for regulatory decision-making and detail key examples of how this evidence has been used. They discuss:
- FDA Guidance and Documentation;
- Practicalities of Relying on RWD/RWE; and
- Premarket and Postmarket Obligations.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kristin Zielinski Duggan, Partner, Hogan Lovells; and Sally Gu, Senior Associate, Hogan Lovells