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.
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Webinar Training Pass
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Description: Regulatory experts Susan Schniepp, Denyse Baker and Cylia Chen Ooi deliver an overview of the FDA’s draft guidance on quality metrics and advise you on how to use this information to improve your firm’s compliance position with the FDA.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
Recorded on: April 19, 2017
Description: Attorney Jason Ma provides an overview of China’s regulatory structure and explains how to work the system to develop, manufacture and market devices in China. He discusses:
- How to comply with arcane Chinese device rules;
- Tips for gaining market approval, including how to find a trustworthy domestic agent to submit your applications;
- What Chinese regulatory authorities look for under a hybrid system where marketing authorization is granted by China’s central FDA agency, but local/regional governments enforce relevant regulations; and
- How China’s agencies function, how they relate to one another and what to prepare for in person-to-person interactions.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jason Ma, Attorney, Mei & Mark LLP
Recorded on: April 18, 2017
Description: Industry experts Aaron Mertens and Jim Polarine explain all the necessary components that will allow end users to be in compliance with FDA, EMA and MHR cleanroom regulations and guidances. They discuss:
- Best practices for rotating disinfectants;
- The critical need to control bioburden and the importance of a sound cleaning and disinfection program; and
- The most current industry methods for applying disinfectants.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Aaron Mertens, Technical Service Specialist, and Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
Recorded on: April 4, 2017
Description: Regulatory submissions expert Michelle McDonough presents a step-by-step guide for developing clinical evaluation reports required by EU authorities to receive CE-marking. She discusses:
- How to establish equivalence with existing products;
- How to conduct a literature search; and
- Whether countries outside the EU may adopt the same requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michelle McDonough, Associate Director, Regulatory & Clinical Affairs, Musculoskeletal Clinical & Regulatory Advisers
Recorded on: March 30, 2017
Description: Quality management specialists Joby George and Mike Edwards discuss the impact of the FDA’s quality metrics initiative on mid-size drugmakers. They cover:
- How and why the initiative developed;
- Reporting by site v. reporting by product; and
- Barriers and limitations facing mid-size companies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Joby George, Product Manager, Sparta Systems, and Mike Edwards, Product Manager, TrackWise
Recorded on: March 24, 2017
Description: Medical device cybersecurity specialists Nick Sikorski and Jongbum Keum discuss the FDA’s final guidance on postmarket management of cybersecurity in medical devices. They cover:
- The FDA’s recommendations for managing postmarket cybersecurity vulnerabilities;
- How manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices;
- How to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA; and
- Techniques for outlining circumstances in which the FDA does not intend to enforce reporting requirements under 21 CFR, part 806.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Nick Sikorski and Jongbum Keum of Deloitte & Touche LLP, Cyber Risk Services
Recorded on: March 23, 2017
Description: Quality systems expert Dan O’Leary explains the FDA’s new device accessories guidance and gives you the tools you need to determine and document whether any of your products are an accessory. He covers:
- The difference between an accessory and a parent device as defined in the guidance document;
- How the definition applies to “software as a medical device;”
- How to determine the classification status of an accessory; and
- The use of the de novo application process for an unclassified accessory.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: March 22, 2017
Description: Business development strategists Ashley Wentworth and Daniel Matlis discuss how cloud-based solutions make it possible to monitor quality metrics in real time wherever the data is generated. They cover how to:
- Drive enhanced product quality at reduced costs and risks while assuring compliance with all applicable regulatory requirements;
- Leverage modern quality systems to improve visibility, control and collaboration across your supply chain;
- Reduce inspection frequency and risk; and
- Reduce data integrity risks before they occur.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ashley Wentworth, Vault Quality Strategy, Veeva Systems, and Daniel R. Matlis, President, Axendia