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: Jan. 13, 2022
Description: Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, explains how to build a quality culture within your organization. She shows you how to:
- Define the leadership objectives that must be at the root of quality initiatives;
- Achieve buy-in so that employees accept and adhere to product integrity and ethical standards;
- Manage product lifecycles, with an open discussion of quality hazards in each stage of business; and
- Promote — and gain wide acceptance for — collaboration, and how to pick your team.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Recorded on: Jan. 12, 2022
Description: Legal and regulatory experts Kristin Davenport, Rujul Desai and Christina Kuhn detail the avenues that you can take to achieve a successful premarket review from the FDA, including:
- FDA premarket review pathways;
- Breakthrough device designation and STeP; and
- Medical coverage of innovative technology (MCIT) pathway.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kristin Davenport, of Counsel, Covington & Burling LLP; Rujul Desai, of Counsel, Covington & Burling LLP; and Christina Kuhn, Associate, Covington & Burling LLP
Recorded on: Jan. 11, 2022
Description: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding is an international leader in preventing medication errors due to brand name confusion. During this webinar she shares:
- How the prescreening process relates to attributes that may contribute to medication errors in naming drugs;
- Suggested methods of evaluating the risk of medication errors related to naming;
- The FDA process for notifying applicants that have similar names in the FDA queue; and
- The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding
Recorded on: Dec. 15, 2021
Description: Explore the legal and regulatory risks that reviewers may spot when assessing marketing materials. You’ll learn about:
- FDA regulations and guidance related to digital and virtual promotion and marketing tactics;
- The future of promotions and marketing; and
- Red flags and risk areas that legal and regulatory reviewers may spot when assessing virtual promotion materials.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Susan Lee, Partner, Goodwin’s Life Sciences Group and FDA Practice; and Elizabeth Mulkey, Senior Associate, Goodwin’s Technology and Life Sciences Group and FDA practice
Recorded on: Dec. 14, 2021
Description: With this expert advice, you’ll eliminate confusion around defining extractables and leachables and learn to determine which regulatory requirements apply. This webinar covers:
- The specifics of what constitutes an extractable or leachable;
- Evaluating USP guidelines and industry standards;
- How to design an extractable and leachable program that meets your development goals and addresses regulatory requirements; and
- Frequent analytical challenges associated with extractables and leachables.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kevin Wells, Group Leader, Eurofins BioPharma Product Testing-Columbia
Recorded on: Dec. 9, 2021
Description: Pharmacovigilance issues? Poor drug safety monitoring or inadequate adverse event reporting can have devastating consequences for patients — and for you. You’ll learn:
- Why pharmacovigilance matters;
- How to comply with premarket and postmarket adverse event reporting requirements;
- How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public; and
- When and why there is a phase 4 (postapproval) study requirement for drugs subject to accelerated approval.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Beth Packman Weinman, Counsel, Member of Ropes & Gray’s Life Sciences Regulatory and Compliance Practice Group
Recorded on: Dec. 9, 2021
Description: Pharmacovigilance issues? Poor drug safety monitoring or inadequate adverse event reporting can have devastating consequences for patients — and for you. You’ll learn:
- Why pharmacovigilance matters;
- How to comply with premarket and postmarket adverse event reporting requirements;
- How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public; and
- When and why there is a phase 4 (postapproval) study requirement for drugs subject to accelerated approval.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kent Malmros, Senior Director, Veeva Systems; and Graham O'Keeffe, General Manager, Veeva Systems
Recorded on: Dec. 8, 2021
Description: Archana Sah, senior vice president of DCT Solutions, Medable and Luisa Sansalone, past clinical research manager at Austin Cancer Center uncover best practices and strategies for developing and deploying decentralized models in oncology trials, including:
- Which oncology protocols are best suited for decentralized clinical trials (DCT);
- Common-use cases for using decentralized methods and technology in oncology;
- Benefits of using a DCT platform purpose-built by clinicians, technology experts and patient advocates who represent the oncology community; and
- Regulatory guidance on hybrid/decentralized trial design.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Archana Sah, Senior Vice President, DCT Solutions, Medable, Inc.; and Luisa Sansalone, Current Clinic Supervisor, Austin Neuromuscular Center
Recorded on: Nov. 30, 2021
Description: Will you know what to do when CDRH issues its Quality System Regulation (QSR) proposed rule? This webinar explains:
- What the most significant changes in the proposed rule will be;
- The anticipated timing for the final rule and expectations for compliance;
- Key changes devicemakers must make to their quality systems; and
- What the implications will be for risk management processes in general.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Julie Larsen, Principal and COO, BioTeknica
Recorded on: Nov. 11, 2021
Description: Connie Hoy of Hoy & Associates Regulatory Consulting, shares lessons learned from successfully leading companies through the MDSAP preparation and audit process and provides insights into what you must know and do to obtain certification, including:
- How to prepare successfully using the MDSAP Companion Document;
- How to ensure your quality system completely covers specific country requirements;
- What to expect in the audit’s registration review portion; and
- How the MDSAP audit is conducted and how differs from an FDA inspection or ISO audit.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting