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: Nov. 10, 2020
Description: Quality experts Michael Moravia and Tom Barlow discuss updated medical device reporting expectations, including ways to harmonize regulation management strategies across multiple countries and territories. Topics include:
- Global harmonization trends and the overall direction for eMDR and EUDAMED;
- Three data upload strategies for EUDAMED reporting;
- Tools that can help your processes adjust automatically with less probability of error; and
- The harmonization of international reporting terminology, especially around adverse events and country codes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michel Moravia, Product Manager of Quality, and Tom Barlow, Strategic Solutions Engineer, ETQ
Recorded on: Oct. 29, 2020
Description: Experts from Greenlight Guru provide insight on industry challenges and barriers to demonstrating closed-loop traceability within a quality management system. They discuss:
- Using purpose-built tools with the latest technologies;
- Optimizing the quality management system for traceability;
- Increasing visibility into relationships withing the quality system; and
- Understanding the impact of change.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Taylor Brown, Senior Medical Device Guru, Tom Rish, Senior Medical Device Guru, and Jason McKibbin, COO, Greenlight Guru
Recorded on: Oct. 29, 2020
Description: A panel of regulatory experts provides tips for evaluating and addressing the new drug patent and exclusivity provisions. They discuss:
- Key resources for drug patent and exclusivity information, including the FDA’s Orange Book and other online CDER resources;
- Key considerations in confirming the duration of patents and exclusivity, such as additive pediatric exclusivity or patent term extensions;
- Timelines and milestones in the patent certification process, including certification to FDA, direct notifications to new drug applications and patent holders and their effect on clearance/approval timelines; and
- Interactions with the drug patent holder when needed, including notifications and rights of reference.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Christina Markus, Partner, King & Spalding, Genevieve Michaux, Partner, King & Spalding, Jessica Ringel, Counsel, King & Spalding, and Quynh Hoang, Consultant, King & Spalding
Recorded on: Oct. 27, 2020
Description: Clinical research operations experts Ken Lownie and Jill Heinz explore the challenges that face sites and a set of strategies to overcome them. They cover:
- An understanding of how ClinOps software fits into the world of the clinical site;
- An example of how one clinical site manager brought in a full range of software solutions successfully; and
- A perspective on the state of the software systems and solutions available today.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ken Lownie, Head of North American Operations, Agatha Life Sciences, and Jill Heinz, President and Director of Clinical Research, Injury Care Family/ Family Care Research
Recorded on: Oct. 27, 2020
Description: A panel of clinical trial experts discusses the lack of diversity in clinical trials and ways in which progress can be made to expand inclusiveness. They cover:
- The current state of diversity in FDA-regulated trials;
- Steps toward better outreach to minority and disadvantaged communities;
- Working with local organizations and disease associations to increase minority participation; and
- Achieving greater clinical research literacy and understanding within minority communities.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lori Abrams, Executive Director of Patient Advocacy and Diversity, WCG Clinical; Ken Getz, Deputy Director and Research Professor, Tufts Center for the Study of Drug Development (CSDD); Zak Smith, Senior Research Analyst, Tufts CSDD; and Jasmine Benger, Associate Director of Research Services, CISCRP
Recorded on: Oct. 22, 2020
Description: Patent attorney Joanna Brougher shares strategies companies can use to develop strong patent portfolios. She discusses:
- How patents and the FDA regulatory process overlap, including during the drug approval process;
- The differences between patent exclusivity and FDA exclusivity;
- Strategies for using exclusivity to build a strong patent portfolio and protect against competitors;
- Potential weaknesses in patents and how FDA exclusivity can help maintain market protection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Joanna Brougher, Owner and Principal, BioPharma Law Group
Recorded on: Oct. 21, 2020
Description: Regulatory affairs consultant Mary Vater explains how the FDA is modernizing the 510(k) device clearance process. She discusses:
- Implications for companies who choose predicates cleared more than 10 years ago;
- Understanding and using third-party reviewers;
- How the FDA is addressing changing biocompatibility requirements; and
- Issues around reprocessed single-use devices.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mary Vater, Consultant, Medical Device Academy
Recorded on: Oct. 21, 2020
Description: Regulatory experts Gary Saner and Carolina Wirth discuss opportunities for growing your OTC portfolio and the complicated compliance issues that may arise during that effort. They cover:
- FDA OTC monograph reform;
- Consequences of the COVID-19 pandemic;
- Impact on existing OTC products; and
- Impact on private label distributors.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Gary Saner, Senior Manager, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory
Recorded on: Oct. 20, 2020
Description: FDA regulatory expert Keith Webber explains the FDA’s most important coronavirus-related guidance. He covers:
- GMP manufacturing considerations;
- Supply chain drug and biologics inspections; and
- COVID-19 vaccine guidance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Keith Webber, Senior Associate, Lachman Consultant Services
Recorded on: Oct. 15, 2020
Description: Medical device regulatory expert Dan O’Leary explains the importance of medical device reliability and the tools and methods you need to prove it. He discusses:
- The concept of maintainability;
- Availability as the combination of reliability and maintainability;
- Distinguishing between safety and reliability; and
- The relationship between reliability and warranty cost.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O'Leary, President, Ombu Enterprises