Simplifying Global Compliance
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!
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Webinar Training Pass
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
Transcript: Download the transcript
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.
Recorded on: Feb. 8, 2017
Description: PDA task force members Denyse Baker, Emma Ramnarine, Melissa Seymour and Dr. Anders Vinther discuss PDA’s program to reduce hurdles to pharmaceutical manufacturing innovation caused by disparate national regulations that discourage changes. The program’s objectives include:
- Fostering a science and risk-based approach to post-approval change management and regulatory decisionmaking;
- Encouraging international convergence/standardization; and
- Managing post-approval changes through the use of an effective Product Quality Systems (PQS).
Presentation: Download the presentation
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Speakers: Dr. Anders Vinther, Chief Quality Officer, Sanofi Pasteur; Emma Ramnarine, Senior Director, Head of Global Biologics QC Network, Genentech/Roche; Melissa Seymour, Vice President of Global Quality Control, Biogen, Inc.; Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment, CDER, FDA
Recorded on: Feb. 1, 2017
Description: Food and drug law expert Jim O’Reilly explains new mandates set by the 21st Century Cures Act and how they will change medical device regulations in several key areas, including data development, clinical approvals, breakthrough devices, inspections and humanitarian device exemptions. He discusses:
- How Congress has thrown a curve at the FDA’s stringent review process, enabling far easier approval for lower-risk devices;
- How the FDA intends to implement the new acceptance program for foreign medical device research; and
- What effect the act’s emphasis on “less burdensome” regulations will have on the industry.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim O’Reilly, Professor of Law (Retired), University of Cincinnati College of Law
Recorded on: Jan. 31, 2017
Description: Medical device expert Grace Fu Palma discusses recent developments in Chinese manufacturing regulations, including new GMPs, self-inspections, foreign inspections and trends in enforcement. She covers:
- Implementation of the new GMPs, including the procedural rules for inspections;
- Transfer of manufacturing sites and amendment of manufacturing and device licenses;
- Policies and rules on contract manufacturing for medical devices; and
- Handling self-inspections and evaluations of past compliance, including recent examples.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Grace Fu Palma, CEO, China Med Device, LLC