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: 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.
Presentation: Download the presentation
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.
Presentation: Download the presentation
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.
Presentation: Download the presentation
Transcript: Download the transcript
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
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Speakers: Steve Terman, Principal Attorney, Olson Frank Weeda Terman Matz, and Gordon Schatz, President, Schatz Reimbursement Strategies
Recorded on: Feb. 15, 2017
Description: Food and drug law expert Jim O’Reilly outlines the major changes the act will make in the way drugmakers operate. He discusses:
- How Congress has thrown a curve at the FDA’s often stringent review process, enabling far broader acceptance of submitted experience data;
- How to avoid supplemental NDAs on new indications by pitching to insurers for their provider formularies without FDA control;
- How to utilize patient input and patient experiences in pre-approval submissions; and
- How to accelerate approval of your new uses for drugs and still stay in compliance with current FDA regulation and guidance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim O’Reilly, Professor of Law (Retired), University of Cincinnati College of Law
Recorded on: Feb. 9, 2017
Description: International trade attorney Jennifer Diaz discusses opportunities and challenges for doing business in Cuba. She covers:
- FDA and other government obstacles that continue to impede U.S.-Cuban commerce;
- What kinds of medical products and foods can be exported to Cuba under the latest FDA and Customs guidance; and
- Details and nuances of the latest trade regulations as they relate to the Cuban trade embargo.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jennifer Diaz, Founding Partner, Diaz Trade Law, P.A.