The Webinar Training Pass

The 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.

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: 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

Recorded on: March 2, 2017

Description: Andrew S. Ittleman of Fuerst Ittleman David & Joseph, PL examines the potential impact of the 21st Century Cures Act and related developments on regenerative medicine. They cover:

  • Provisions of the 21st Century Cures Act directly impact the regenerative medicine;
  • How the legislation creates new conditional pathways;
  • The key terms impacting regenerative medicine regulation; and
  • How FDA’s Center for Biologic Evaluation and Research has been reorganized.

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Transcript: Download the transcript

Speaker: Andrew S. Ittleman, Founder and Partner, Fuerst Ittleman David & Joseph, PL

Recorded on: March 1, 2017

Description: Sean Boyd and Daniel R. Matlis discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient. They cover:

  • How to stop routine FDA inspections and forego pre-approval inspections;
  • How the Case for Quality is creating a competitive marketplace for device quality;
  • How to manage results using quality tools; and
  • What are the quality outcome metrics FDA will collect and monitor.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: CAPT Sean Boyd, Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance; Daniel R. Matlis, President, Axendia and Francisco (Cisco) Vicenty, Program Manager, Case for Quality, US Food And Drug Administration

Recorded on: Feb. 28, 2017

Description: Industry thought leaders Susan Schniepp, Sharon McAndrews and Tamara Jordan discuss fundamentals and critical elements for conducting an internal audit. They cover:

  • Regulatory requirements for internal auditing;
  • Benefits of the internal audit system;
  • Audit reporting; and
  • Corrective actions and next steps.

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Transcript: Download the transcript

Speakers: Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.; Sharon McAndrews, CEO, McAndrews Consulting; and Tamara Jordan, CEO, Compliance Consulting Partners

Recorded on: Feb. 23, 2017

Description: Quality systems expert Dan O’Leary identifies the most frequently cited steps in the corrective and preventive action processes. He discusses:

  • The three parts of the FDA’s corrective and preventive action system;
  • QSIT expectations for each step;
  • How to correct similar problems in your QMS; and
  • How to review warning letters to glean lessons from others’ mistakes.

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Speaker: Dan O’Leary, President, Ombu Enterprises, LLC

Recorded on: Feb. 22, 2017

Description: Attorneys Steve Terman and Gordon Schatz explain how to strategically blend reimbursement with FDA regulatory. They discuss:

  • How to evaluate the 510(k)/PMA options in terms of maximizing reimbursement;
  • What key reimbursement questions must be asked in advance of selecting the FDA approval pathway;
  • How to decide what data is needed to support both a favorable FDA outcome and obtain the desired reimbursement; and
  • The 7 steps to reimbursement success.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Steve Terman, Principal Attorney, Olson Frank Weeda Terman Matz, and Gordon Schatz, President, Schatz Reimbursement Strategies