Simplifying Global Compliance
The Webinar Training Pass
Now get all the training you need – all in one place, and all for one low price!
The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
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.
Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.
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Webinar Training Pass
Recorded on: May 31, 2017
Description: Global drug and device expert Michael Burke explains how the upcoming Brexit separation from the European Union may take shape. He discusses:
- How Brexit may affect drug and device companies’ operations;
- How marketing authorization will be affected in the EU and UK; and
- Possible new locations for European Medicines Agency headquarters.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michael Burke, Partner, Arnall Golden Gregory
Recorded on: May 30, 2017
Description: Life Sciences experts Carmen Medina and Daniela Jansen discuss steps to take to prepare for the FDA’s quality metrics program. They cover:
- Understanding the FDA’s quality metrics vision;
- Developing enterprise-wide quality metrics for product lifecycle;
- Linking to lifecycle process validation; and
- Alternative Metrics.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Carmen Medina, Vice President, Technical Services, PAREXEL Consulting; and Daniela Jansen, Director, Solution Marketing, Dassault Systèmes BIOVIA
Recorded on: May 23, 2017
Description: Supplier contract specialist Courtney Stevens walks you through the essentials of supply contracts. She covers:
- How to approach a contract negotiation;
- What every contract must include;
- Insurance clauses and certificates of insurance; and
- Audit provisions for further protection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Courtney Stevens, Senior Attorney-Risk Management and Loss Control, MedMarc Insurance Group
Recorded on: May 18, 2017
Description: Quality systems expert Dan O’Leary explains the requirements of the FDA, EU and ISO for analyzing trends in medical device complaints. He discusses:
- Systems for analyzing, classifying and coding complaints;
- FDA-specific coding for MDRs;
- Coding derived from risk management files; and
- Linking complaints, coding and risk management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: May 17, 2017
Description: Three former colleagues of new FDA Commissioner Scott Gottleib discuss how his qualifications make him the best choice for the position. They cover:
- How his experience and public statements indicate what his agenda as commissioner may include;
- How he may approach staffing and funding challenges;
- Potential increased predictability in the approval process and more in-depth guidance; and
- A new forward-looking approach to using real-world evidence.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Marc Scheineson, Partner, Alston & Bird LLP; Peter Pitts, Co-founder and President, Center for Medicine in the Public Interest
Recorded on: May 9, 2017
Description: International auditing expert Brian Ludovico explains the benefits of participating in the MDSAP and gives an update on the program’s status. He covers:
- The benefits of substituting MDSAP audit reports for FDA routine inspections;
- How to identify international regulators now participating in the MDSAP pilot process or soon to be;
- How current participants in the program are faring; and
- How the MDSAP affects pre- and post-market approval applications, device classification and ISO 13485 compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences
Recorded on: May 9, 2017
Description: Quality systems expert Susan Leister discusses the recent revision of the ICH E6 Good Clinical Practice guidance and the impact changes will have on trial sponsors and sites. She covers:
- Good documentation practices;
- Risk-based approach to trial monitoring;
- Internal auditing and quality management; and
- Investigator and sponsor responsibilities.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Leister, Director of Quality Assurance, Technical Resources International
Recorded on: April 28, 2017
Description: Regulatory experts Susan Schniepp, Denyse Baker and Cylia Chen Ooi deliver an overview of the FDA’s draft guidance on quality metrics and advise you on how to use this information to improve your firm’s compliance position with the FDA. They discuss:
- How the FDA intends to use the data collected;
- Who is required to comply;
- When the data must be reported; and
- The status of PDA’s Quality Assessment Tool pilot program.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.; Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; and Cylia Chen Ooi, External Affairs Senior Manager, International Quality, Amgen
Recorded on: April 27, 2017
Description: Industry experts David Wolf, Dave Hadfield, Daniel Matlis and Chris Hoag discuss the benefits of using product lifecycle management to boost product quality, increase innovation, speed time to market and improve patient safety. They cover:
- Managing risk to drive the safety and quality of products and processes;
- Improving measurement of quality metrics; and
- Achieving a preventive manufacturing model with an agreed risk-benefit framework.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: David Wolf, Program Director, Medical Device Strategy, PTC; Dave Hadfield, Senior Manager, Kalypso; Daniel Matlis, President, Axendia; and Chris Hoag, Director, Global RA/QA eSystems, Stryker
Recorded on: April 20, 2017
Description: Medical device regulatory expert Dan O’Leary provides a guide to rules devicemakers must understand. He discusses:
- The risk management process in ISO 14971:2007 and the EU variant in EN ISO 14971:2012;
- How biocompatibility fits into the risk management process;
- How harmonized standards help implement essential requirements; and
- The biocompatibility expectations of the EU’s new Medical Device Regulation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC