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.
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Webinar Training Pass
Recorded on: May 4, 2016
Description: Quality manufacturing expert Alexandre Alain discusses the potential causes for repeat CAPAs in an organization and ways to effectively reduce their occurrence. He covers:
- How to leverage risk tools to break the cycle;
- Effective strategies to ensure CAPAs are completed correctly;
- How to link CAPAs to change control; and
- How leveraging technologies and automated tools mitigate the risk of recurrence.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Alexandre Alain, Life Science Product Manager, VERSE Solutions
Recorded on: April 28, 2016
Description: Enforcement and regulatory experts Scott Bass and Bill McConagha discuss areas in which dietary supplement stakeholders face increasing liability and how they can mitigate that liability. They cover:
- CEO and senior officer liability;
- GMP awareness; and
- Recent FDA and DOJ enforcement activities.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Scott Bass, Partner, and Bill McConagha, Partner, Sidley Austin LLP
Recorded on: April 26, 2016
Description: Quality systems expert Dan O’Leary explains recordkeeping requirements for medical devices and clarifies the differences between the Device Master Record, the Device History Record and the Quality System Record. He discusses:
- ISO 13485:2016
- Unique Device Identification requirements; and
- Special cases, such as Class I devices and specification developers.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: April 25, 2016
Description: Quality assurance expert Susan Schniepp discusses how to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites. She covers:
- Planning and project management;
- Transfer of analytical assays;
- Small-scale verification at receiving site; and
- Pre-GMP engineering runs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan J. Schniepp, Fellow, Regulatory Compliance Associates, Inc.
Recorded on: April 21, 2016
Description: Biosimilars expert Nathan Doty examines the outlook for the industry and discusses:
- Immunogenicity;
- Loss of efficacy; and
- Switching without interchangeability.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nathan Doty, Associate Director, Biotherapeutics Regulatory Affairs, Abbvie
Recorded on: April 20, 2016
Description: Clinical trial policy advisor Beverly Lorell discusses how to keep your focus on data collection and integrity. Topics include:
- Inadequate recordkeeping;
- Inadequate accountability for the investigational product;
- Inadequate communication with the IRB;
- Inadequate subject protection — failure to report AEs and informed consent issues; and
- Inadequate monitoring.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Beverly Lorell, Senior Medical and Policy Advisor, FDA & Life Sciences Practice Group, King & Spalding
Recorded on: April 13, 2016
Description: Regulatory specialist Michele Buenafe discusses the current regulatory climate for mobile medical apps, issues that are yet to be resolved and expectations for future developments and the direction of regulatory policy in this space. She covers:
- Mobile medical apps guidance;
- FDASIA Health IT Report;
- FDA enforcement discretion; and
- FTC enforcement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michele Buenafe, Partner, FDA Practice, Morgan, Lewis & Bockius, LLP
Recorded on: April 5, 2016
Description: Global regulatory affairs specialists Fernando Ferrer and Silvia Bendiner present the economic and regulatory outlook in various Latin American states. They discuss:
- Argentina;
- Brazil;
- Colombia;
- Mexico; and
- Puerto Rico.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Fernando Ferrer, Head of Global Consulting in Business and Operations, Multinational Partnerships, LLC and Silvia Bendiner, Director of Regulatory Affairs for Latin America, Mapi Group
Recorded on: March 31, 2016
Description: Consultants Glen Potvin and Lesley Stewart describe a proven approach to uncover and address data integrity issues within companies and their partner networks. They discuss:
- How to establish a “right to win mentality” through proactive steps and surveillance activities;
- How to characterize the scale and scope of issues;
- How to design and deploy the remediation strategy; and
- Best practices for tailoring solutions to the problems identified.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Glen Potvin, Senior Director, and Lesley Stewart, Principal Consultant, Quintiles Consulting
Recorded on: March 31, 2016
Description: Attorneys Anuj Desai and Alan Minsk explain how to minimize risks of FTC and FDA enforcement for the use of native advertising techniques. They cover:
- The FTC definition of deceptive advertising;
- How to ensure disclosure language is clear and visible; and
- How to apply FDA rules on labeling and promotion in the absence of guidance specific to native advertising.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Anuj Desai and Alan Minsk, Partners, Arnall Golden Gregory