The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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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 10, 2020
Description: Device compliance expert Dan O’Leary discusses steps to prepare for notified body review under EU-MDR. He covers:
- Auditing quality management system elements;
- Requirements for the Annex IX application;
- The notified body document review process; and
- Understanding the notified body audit based on Annex VII.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: April 8, 2020
Description: Clinical research compliance expert Eve Brunts explains how to overcome the challenges of clinical trial billing compliance using applicable coverage and coding requirements and implementing appropriate policies and operational processes. She discusses:
- Medicare coverage and coding requirements, including Medicare clinical trial policy and investigational devices;
- Federal and state laws addressing coverage of clinical trial services for other third-party payers, including comparisons of federal and particular state provisions;
- Common clinical trial agreement contracting approaches; and
- Development of a clinical trials coverage analysis.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eve Brunts, Partner, Ropes & Gray
Recorded on: April 7, 2020
Description: Regulatory expert Bradley Merrill Thompson provides a comprehensive overview of current guidance on clinical decision support (CDS) software and discusses:
- Impact of the 21st Century Cures Act on CDS regulation;
- How to determine what types of CDS software functions do not meet the FDA’s definition of a device; and
- How to assess which types of software meet the definition of a device for which the FDA may not enforce compliance under device requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Bradley Merrill Thompson, Shareholder, Epstein Becker & Green
Recorded on: March 31, 2020
Description: Attorneys Michael Werner and Sara Klock explain the latest federal regulations for informed consent and human subject protection when using digital technologies. They discuss:
- How digital technologies used to gather, analyze and report healthcare data for medical treatment purposes or to promote a healthy lifestyle can also be used for research purposes;
- How to design clinical trials using digital technologies that comply with the 21st Century Cures Act and changes to the Common Rule; and
- How to identify factors likely to determine whether and to what extent certain technologies are regulated as medical devices by FDA.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael Werner, Co-Leader of Holland & Knight's Healthcare & Life Sciences Team, and Sara Klock, Member of Holland & Knight's Public Policy & Regulation Group
Recorded on: March 27, 2020
Description: Human behavior expert Ginette Collazo discusses the psychology of human error and how to investigate and fix problems. She covers:
- Determining when human error is a causal factor of quality and compliance issues;
- Understanding the types of human error, including intentional and unintentional errors of omission and commission; and
- Measuring human error rates by using the root cause determination tool and cognitive load tool.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ginette Collazo, CEO, Human Error Solutions
Recorded on: March 19, 2020
Description: Former FDA Commissioner Mark McClellan gives an overview of emerging trends in medical product development, including efforts to further improve development and regulatory review. He discusses:
- The overall landscape of value-based payment and delivery reforms and what you must know about their growing linkages to medical product development;
- Increasing concerns associated with the price for transformative medical technologies like gene and cell therapies, and how these anticipated prices are driving stakeholders to explore new types of contract mechanisms and alternative payment models;
- Insight into new policy development areas emerging around challenges with payer coding, coverage and payment processes for innovative medical technologies; and
- The growing need for a real-world data and evidence development infrastructure and its anticipated role in improving your development of medical products as well as regulation and care delivery.
Presentation: Download the presentation
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Speakers: Mark McClellan, Director and Robert J. Margolis Professor of Business, Medicine and Policy, Duke-Margolis Center for Health Policy
Recorded on: March 18, 2020
Description: The FDA’s Douglas Throckmorton discusses how the agency is currently administering the GMP requirements to be followed in the case of drug shortages. He covers:
- The pivotal role manufacturers can play in assessing potential threats to quality;
- The crucial role that data and transparency play in quality issues affecting drug shortages; and
- How drug manufacturers can stay in compliance with FDA regulations on cGMP quality.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Douglas Throckmorton, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA, and Peter Pitts, President, Center for Medicine in the Public Interest
Recorded on: March 11, 2020
Description: Device systems expert Dan O’Leary explains how to predict misuse errors and make risk management plans that comply with the revised ISO 14971:2019. He discusses:
- What you must know about the regulatory status of the standards in the U.S., EU and Canada;
- How to comply with the FDA Center for Devices and Radiological Health’s approach to usability engineering;
- How to incorporate the concepts of formative and summative evaluation; and
- Which inputs you must add to your user interface specification.
Presentation: Download the presentation
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Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Feb. 27, 2020
Description: FDA regulatory expert Scott Lassman explains the requirements of pharmaceutical exclusivity. He discusses:
- The new standard governing the scope of 3-year clinical investigation exclusivity;
- Orphan drug exclusivity; and
- Current legislative proposals.
Presentation: Download the presentation
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Speaker: Scott Lassman, Principal, Lassman Law & Policy
Recorded on: Feb. 25, 2020
Description: Trade attorney Jennifer Diaz discusses strategies for resolving FDA and Customs and Border Patrol (CBP) issues. She covers:
- Analysis of important recent enforcement actions;
- Customs and Border Protection detention and seizure processes;
- Mitigating and aggravating factors in enforcement; and
- Submitting a petition for relief.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jennifer Diaz, President, Diaz Trade Law and Diaz Trade Consulting