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: June 3, 2020
Description: Life sciences litigator Nicholas Mitrokostos discusses the new wave of expiring regulatory exclusivities regarding biologics and how the FDA is managing new biosimilar product applications. He covers:
- The deemed-to-be-a-license provision;
- Demonstrating interchangeability with a reference product;
- Clinical immunogenicity considerations for biosimilar and interchangeable insulin products; and
- Promotions, labeling, and advertising of biologic and biosimilar products.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nicholas Mitrokostas, Partner, Goodwin Procter
Recorded on: June 2, 2020
Description: Device regulatory expert Jon Gimbel explains what you must know to meet EU-MDR’s and EU-IVDR’s requirements for clinical and performance evaluation reports. He discusses:
- Ideas for recommended report structures;
- How literature searches can be used within these evaluations; and
- Common notified body findings and pitfalls, including those related to equivalence and measurable objectives.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jon Gimbel, Executive Director, Regulatory and Quality Solutions
Recorded on: May 29, 2020
Description: Global compliance expert John McKay discusses how to continue operations under pandemic conditions when working with Chinese and Indian suppliers. He covers:
- Remote and desktop audits;
- Methods to prevent drug shortages; and
- CAPA for suppliers to implement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John McKay, CEO and Chief Compliance Officer, Q1 Associates
Recorded on: May 28, 2020
Description: International standards expert Eamonn Hoxey examines recent and upcoming changes to international medical device guidelines and regulations. He discusses:
- The relationship between ISO 13485 and 21 CFR 820;
- The relationship between ISO 13485 and EU-MDR;
- Implications of the reconfirmation of ISO 13485:2016 on quality management systems requirements for medical devices; and
- The future direction of generic management system requirements, including ISO 9001.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eamonn Hoxey, Technical Writer, Trainer and Consultant
Recorded on: May 27, 2020
Description: Clinical researcher Marina Malikova examines how changes to the international good clinical practice guideline have affected trials. She discusses:
- New sections on investigator responsibilities and the substantial new sponsor section on quality management;
- Implementation of revised regulatory guidelines, including those affecting globalization issues;
- Introduction of risk-based quality management; and
- Development of SOPs, including those on validation and electronic records.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Marina Malikova, Assistant Professor of Surgery and Executive Director of Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Recorded on: May 21, 2020
Description: Supply chain experts Megan Biernat and Steve Tallant discuss Merck’s approach to supply chain security. They cover:
- How the company uses blockchain technology to create a secure link between physical and digital;
- How it leverages digital eFingerprint technology; and
- A next-generation approach to digitally protect and connect pharmaceutical products.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Megan Biernat, Technical Analyst, Merck, and Steve Tallant, Senior Director of Market Development, Systech
Recorded on: May 20, 2020
Description: Medical device regulatory experts Kim Young and Chris Nichols discuss ways to improve the efficiency of regulatory operations information management. They cover:
- How to integrate the critical aspects of EU-MDR compliance;
- What you must consider when deploying a sustainable EU-MDR compliance framework;
- How to avoid challenges and setbacks when searching for the right technology and tools; and
- Modernizing processes, technologies and tools.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kim Young, Instem Director of Global Regulatory Intelligence and Chris Nichols, Regulatory Solutions Specialist, Instem
Recorded on: May 19, 2020
Description: Clinical operations and compliance experts discuss methods for conducting trials under the current pandemic conditions. They cover:
- Shifting FDA and IRB guidelines;
- Technology options for supporting clinical trials; and
- Home health and direct-to-patient options.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kim Kundert, Vice President of Operations, VirTrial, Robin Marcus, Chief Strategy Officer, GlobalCare Clinical Trials and Melanie Flores, Vice President of Compliance, IntegReview
Recorded on: May 14, 2020
Description: Medical device expert Dan O’Leary discusses how Microsoft Excel can help predict outcomes. He covers:
- Using Excel to generate random numbers;
- Examining the relationship between probability density functions and cumulative density functions; and
- Applying Excel functions that can produce random numbers from various statistical distributions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: May 14, 2020
Description: Regulatory expert Allison Fulton discusses best practices in complaint management. She covers:
- Evaluate trends in regulatory enforcement;
- The importance of consistent complaint intake in measuring effectiveness; and
- Auditing the complaint management system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Allison Fulton, Partner, Sheppard Mullin