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: Dec. 8, 2020
Description: Food and drug attorney Alan Minsk discusses the FDA’s new labeling guidance on instructions for use (IFU). He covers:
- The kind of language IFUs should be written in to be patient friendly;
- What the guidance recommends in terms of voice, commands and sentences;
- Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal; and
- Recommendations the FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Alan Minsk, Partner, Arnall Golden Gregory
Recorded on: Dec. 3, 2020
Description: Validation expert Tim Fischer discusses the FDA’s new Computer System Assurance (CSA) and its focus on quality risk management. He covers:
- Critical risk thinking;
- Computer systems to which CSA applies;
- Performance metrics needed; and
- Transition and next steps.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Great Solutions
Recorded on: Dec. 2, 2020
Description: Information systems experts Pradip Banerjee, Brian Friel and Bob Friedman discuss the uses of predictive technologies. They cover:
- Modern technologies and algorithms to strategize, plan and implement predictive risk management solutions;
- Digital technologies to help identify, predict and manage risks of the entire clinical trials process;
- Real-time data monitoring and data integrity issues and solutions; and
- Technologies that can help prioritize actions to make operations more efficient.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Pradip K. Banerjee, Chairman of the Board and Chief Executive Officer, Brian Friel, Compliance and Risk Specialist, and Bob Friedman, Chief Technologist and Chief Solutions Architect, Xybion
Recorded on: Dec. 2, 2020
Description: Regulatory experts Stefanie Doebler and Christopher Hanson discuss FDA requirements for promotion — incorporating claims substantiation, fair balance and off-label promotion — and the key differences between drug and device promotion. They cover:
- The primary requirements for advertising and promotion set forth in the Food, Drug and Cosmetics Act and implementing regulations;
- The FDA’s recent guidance on promotion consistent with the approved labeling;
- The scope of the prohibition on preapproval promotion; and
- The difference between promotion and disease awareness communications.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Stefanie Doebler, Partner, Covington & Burling, and Christopher Hanson, Special Counsel, Covington & Burling
Recorded on: Nov. 19, 2020
Description: Quality systems expert Dan O’Leary discusses the coming changes to device certification, obtaining a UK Conformity Assessed (UKCA) mark and registering your device with the Medicines and Healthcare products Regulatory Agency (MHRA). Topics include:
- Making sense of the UK conformity assessment bodies;
- The separate rules for Northern Ireland; and
- Some of the planned changes in the UK regulations.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Nov. 19, 2020
Description: Representatives of Mercy Health discuss the challenges of connecting study teams in multiple states to ensure billing efficiency and compliance. They cover:
- Recent coverage analysis trends;
- Examples and best practices of communication within an organization to ensure study start-up sets the table for compliant billing decisions;
- Importance of coverage analysis utilization by multiple teams within an institution to protect the organization and research participants; and
- Examples of a “living document” that evolves throughout the lifecycle of a clinical trial, including amendments and change requests.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Aubrey Smith and Tiffani Smith, Managers of Business Operations, Mercy Health; Geoffrey Schick, Senior Consultant, WCG Clinical; and Amanda Miller, Manager of Quality and Development, WCG Clinical
Recorded on: Nov. 19, 2020
Description: Pharmacovigilance expert Graeme Ladds discusses best practices around resource reductions, safety reporting, labeling, compliance documents and reporting adverse events. He covers:
- Prioritizing product risks and communicating those risks to regulators during the COVID-19 pandemic;
- Complying with expedited reporting rules during the health crisis;
- Creating world-class SOPs, including those that contain exceptions to accommodate COVID-19 issues; and
- Constructing real-world timelines that take into account compliance requirements around COVID-19.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Graeme Ladds, CEO, PharSafer Associates
Recorded on: Nov. 17, 2020
Description: Clinical trial operations experts Barry Milton, Andy Lawton and Elvin Thalund discuss the concepts of vendor oversight and risk management under ICH E6(R2). They cover:
- The intended purpose of ICH regulations to implement industry best practices;
- How current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidances; and
- How implementing quality-by-design principles can ensure study risk assessment in your vendor oversight – end-to-end.
Presentation: Download the presentation
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Speakers: Barry Milton, Head of Global Program Management, Novartis Institutes for Biomedical Research; Andy Lawton, Consultant, Risk Based Approach Ltd.; and Elvin Thalund, Director of Industry Strategy, Oracle Health Sciences
Recorded on: Nov. 16, 2020
Description: Medical device legal expert Evan Phelps shares the most significant issues that could arise when implementing the FDA guidance on breakthrough devices. He covers:
- The basics of the FDA’s Breakthrough Device Program;
- Program benefits and how the designation will push a device to market earlier;
- FDA criteria to identify breakthrough devices, including specific statutory criteria from Appendix I of the Breakthrough Devices Program Final Guidance; and
- Key elements the FDA uses to review breakthrough device applications.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Evan Phelps, Partner, Amin Talati Wasserman
Recorded on: Nov. 10, 2020
Description: Device quality and regulatory expert Linda Lovett explains how to establish and implement a comprehensive supplier management system using risk management principles. She discusses:
- Setting up a risk-based supplier program that meets quality and regulatory requirements;
- Identifying quality criteria based on supplier risk level (key, custom specification, industry standard and service suppliers);
- Applying risk-based supplier qualifications, auditing and monitoring; and
- Applying examples of supplier quality and risk metrics/key performance indicators.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Linda Lovett, CEO, Lovett Consulting