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: May 5, 2020
Description: Training experts Crissy MacDonald and Steve Whittaker discuss how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance. Topics include:
- How to address common challenges in building an effective GxP training program;
- Best practices of creating an enterprisewide learning strategy; and
- How a unified GxP training environment delivers better training and quality outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Crissy MacDonald, Vice President of Client Delivery, The Avoca Group and Steve Whittaker, Senior Consultant, The Avoca Group
Recorded on: April 30, 2020
Description: Training experts John Constantine and Kent Malmros discuss how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance. Topics include:
- How to address common challenges in building an effective GxP training program;
- Best practices of creating an enterprisewide learning strategy; and
- How a unified GxP training environment delivers better training and quality outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director of Vault Training, Veeva Systems
Recorded on: April 23, 2020
Description: Regulatory expert Dan O’Leary discusses the postmarket surveillance (PMS) requirements under the upcoming EU-MDR. He covers:
- How to prepare your PMS plan;
- How to prepare other related plans — the complaint management plan, the trend report plan; and
- How to determine the reports required for the PMS system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: April 22, 2020
Description: Privacy and data protection attorney Stephan Grynwajc provides a comprehensive overview of the rules that apply to the collection of EU personal data and its use in clinical trials. He discusses:
- The GDPR, the ePrivacy Directive, the Clinical Trials Directive and the draft Clinical Trials Regulation;
- Adapting internal policies and procedures to comply with EU laws and regulations;
- Understanding international transfers of data under the 1995 Privacy Directive/GDPR and the interplay between the GDPR and the EU and Swiss Privacy Shield Frameworks; and
- EU privacy enforcement trends following the adoption of the GDPR.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Stephan Grynwajc, Managing Partner, Law Office of S. Grynwajc
Recorded on: April 21, 2020
Description: Medical device regulatory experts Kristin Davenport and Christina Kuhn explores the nuances of the FDA’s regulation and enforcement related to digital health tools. They discuss:
- Determining which FDA policies apply when wearables are regulated, including how to comply with the FDA’s guidances on clinical decision support;
- Specifying differences between platforms and individual apps; and
- Assessing considerations for artificial intelligence and the intersection of artificial intelligence and the FDA regulation.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kristin Davenport, Of Counsel, Covington & Burling, LLP and Christina Kuhn, Associate, Covington & Burling, LLP
Recorded on: April 16, 2020
Description: Medical device regulatory expert Dan O’Leary presents best practices, processes and methods for compliant change management. He discusses:
- The overarching change management process and methods;
- How to apply the process to specific change types;
- Determining the change interactions in the change types; and
- Identifying the similarities and differences across quality management system requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
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