The Webinar Training Pass

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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 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

Recorded on: March 21, 2017

Description: FDA law specialists David Fox and Robert Church discuss the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. They cover:

  • Which FDA centers will take the lead on combination products;
  • Whether you will need a drug to be cross-labeled and approved for use with your device;
  • Why the Office of Combination Products may send your product to the drug center when you designed it to be a device;
  • What your rights and remedies are if you feel that your combination product is not being handled properly by the FDA; and
  • What specific guidance is top priority for the FDA as it regulates combination products under the 21st Century Cures Act.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: David M. Fox and Robert Church, Partners, Hogan Lovells

Recorded on: March 15, 2017

Description: Rich Yeaton and Christine Kielhorn, Ph.D. present five case studies to illustrate key lessons they have learned from implementing the E2500 approach. They cover:

  • Why implement the E2500 standard;
  • Best practices for implementing the E2500 approach;
  • The benefits and limitations of E2500; and
  • 5 valuable real-life case studies.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Rich Yeaton, Owner, Atlantic Technical and Validation Services and Christine Kielhorn, Ph.D., Director of Quality, Atlantic Technical and Validation Services

Recorded on: March 8, 2017

Description: Michael M. Gaba and Shayesteh Fürst-Ladani & Scientific Communication Ltd. discuss the biggest anticipated changes to the EU and U.S. medical device framework in years. They cover:

  • How to handle the EU’s expanded pre-market expectations;
  • How to prepare for amplified post-market surveillance;
  • The extent to which a company’s regulatory processes in the EU and US can be harmonized; and
  • What to expect from the FDA’s new legal authorities to influence medical device approvals.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Michael M. Gaba, Life Science Partner, Holland & Knight LLP, USA and Shayesteh Fürst-Ladani, founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland