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 17, 2023
Description: This webinar provides a refresher of the current regulatory landscape around IVDs and LDTs and how the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) could change it. You will learn about the:
- Current CLIA framework and LDTs
- FDA regulation of IVD tests as medical devices and their regulatory stance towards LDTs
- History and development of the VALID Act and the framework to define and regulate in vitro clinical tests (IVCT)
- Legislative pathways and prospects for the VALID Act to become law and FDA implementation timelines
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael M. Gaba, FDA Practice Vice Chair, Polsinelli; Colleen Faddick, Health Care Operations Practice Chair, Polsinelli; and Christopher C. Rorick, Senior Policy Advisor, Public Policy Practice Group, Polsinelli
Recorded on: May 11, 2023
Description: Andrew Mackinnon, Martha LaManna, and Mel Mann, discuss the benefits of modern clinical trials that help pharma sponsors and CROs demonstrate greater collaboration, appreciation, and understanding for the roles of patients and sites. They cover:
- Strategies for building empathy and human interaction into the digitized trial process;
- The importance of how best to listen to sites and build trusting relationships;
- How to ease the implementation of clinical trial technology and demonstrate why growing pains are normal during digital change; and
- Best practices from other industries that have successfully gone digital and how the clinical trial industry is headed in the right direction.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Andrew Mackinnon, VP and GM eConsent, Medable; Martia LaManna, Director of Customer Success, Innovative Supply Solutions; and Mel Mann, MBA, M.Ed., Patient Advocate & Advisor, Be The Match
Recorded on: May 10, 2023
Description: FDA regulatory experts Kristin Zielinski Duggan and Sally Gu dig into the FDA’s guidance around RWE as support for regulatory decision-making and detail key examples of how this evidence has been used. They discuss:
- FDA Guidance and Documentation;
- Practicalities of Relying on RWD/RWE; and
- Premarket and Postmarket Obligations.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kristin Zielinski Duggan, Partner, Hogan Lovells; and Sally Gu, Senior Associate, Hogan Lovells
Recorded on: April 27, 2023
Description: Wayne L. Pines, president of healthcare at APCO Worldwide and former associate commissioner of the FDA — along with a panel of experts — will share what you must know and do to get ahead of the changes. They will look back at the crucial developments of 2022 and what will likely come in 2023 and beyond, including:
- Adoption of new administrative and personnel practices post-pandemic;
- How the new provisions in the user fee legislation will affect your daily business;
- How key personnel changes in the FDA are impacting policy; and
- How CDER, CBER and CDRH are rethinking the R&D process and their own review and approval standards.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne L. Pines, President, Healthcare, APCO Worldwide; Steven A. Grossman, President, HPS Group; Lowell M. Zeta, Partner, Life Sciences and Global Regulatory Practice, Hogan Lovells US LLP; Cathy Burgess, Partner, Alston & Bird LLP; and Nancy Bradish Myers, JD, President, Catalyst Healthcare Consulting, Inc.
Recorded on: April 26, 2023
Description: Michey Landkof and Rosalind Beasley of Dot Compliance describe the transition from paper and file-based systems to automated quality, and the advantages of a cloud quality management system.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mickey Landkof, general manager and global vice president of sales, and Rosalind Beasley, digital transformation executive at Dot Compliance.
Recorded on: April 20, 2023
Description: Covering traditional health, safety and efficacy concerns, as well as areas like data privacy, identify theft and cybersecurity, this webinar leaves you with the confidence to handle any enforcement situation in medical device development. It covers:
- A comprehensive understanding of how the FDA, DOJ and FTC coordinate their priorities and resources for enforcement actions;
- A review of recent FTC enforcement cases, with a focus on the perils of promoting claims that aren’t supported by science;
- An explanation of the FTC’s health products compliance guidance and other rules; and
- Key updates from the FDA’s guidances on medical device-related cybersecurity.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Claud, Counsel, Hyman, Phelps & McNamara
Recorded on: April 5, 2023
Description: Sundeep Agarwal discusses ways to make Software as a Medical Device (SaMD) post market risk management less complicated and more systematic for your company. He’ll cover:
- Risk Management in SaMD;
- Risk management core activities;
- Residual risk;
- Benefits risk analysis; and
- Post market risk management sources, planning and controls.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sundeep Agarwal, Medical Device Expert & Consultant
Recorded on: April 4, 2023
Description: Quality thought leaders Jason Boyd, Veeva, and Alan Maloney, Accenture will share how a strategy for unifying quality across QA, QC, and manufacturing can optimize QC productivity and improve agility in responding to changes. Come away with:
- An understanding of the most impactful levers for optimizing QC;
- Best practices for driving quality transformation initiatives; and
- Success stories from Top Pharma.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jason Boyd, Sr. Director, Vault LIMS, Veeva Systems; and Alan Maloney, Senior Manager, Accenture
Recorded on: March 15, 2023
Description: Scott Thiel, global head of regulatory policy and intelligence for Hologic, and Jeff Ballyns, director of regulatory strategic planning for innovation at Becton Dickinson and a veteran of the FDA’s Center for Devices and Radiologic Health (CDRH) share techniques you can use to provide objective evidence of compliance. They explain:
- Where the AI/ML technology knowledge gaps are — in industry and the FDA — including what AI/ML can and cannot do when it comes to medical device quality, regulatory and compliance information;
- Common issues and strategies for closing knowledge gaps, including how to optimize the use of AI and ML;
- What to do differently — or not do differently — when it comes to integrating AI/ML into your quality system or production process, including how integration meshes with your SOPs; and
- What issues the FDA sees when reviewing premarket submissions and inspecting facilities with AI/ML-enabled medical devices and AI/ML that supports the quality system and/or production.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott Thiel, Global Head of Regulatory Policy and Intelligence, Hologic; and Jeff Ballyns, Director, Regulatory Strategic Planning for Innovation, Becton Dickinson
Recorded on: March 8, 2023
Description: Eric Henry and Christopher Gates explain the regulatory expectations for cybersecurity and how to craft your design controls practices to execute and defend in compliance with those expectations. They cover:
- How cybersecurity activities fit into traditional design controls and safety risk management for medical devices when integrating into quality management systems;
- What the FDA is already addressing in inspections from its new draft cybersecurity guidance;
- How to address postmarket cybersecurity activities during inspections; and
- Common themes in the current library of cybersecurity regulations, standards and guidance.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Eric Henry, Senior Quality Systems and Compliance Advisor, King & Spalding LLC; and Christopher Gates, Director of Product Security, Velentium