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 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
Recorded on: March 7, 2023
Description: Grace McNally, a senior vice president of regulatory compliance at Greenleaf Health, and a 33-year veteran of the FDA, explains everything you need to know and do regarding the agency’s ongoing use of remote tools, including:
- The FDA’s approach to regulatory oversight during the public health emergency, including its use of remote assessment tools;
- The important differences between mandatory and voluntary assessments;
- FDA priorities and key guidances and other policy documents that describe remote regulatory assessments; and
- Center for Drug Evaluation and Research compliance activity based on remote regulatory assessments.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Grace McNally, Senior Vice President, Regulatory Compliance, Greenleaf Health
Recorded on: Feb. 22, 2023
Description: This interactive webinar discusses how to build, maintain, and deploy a modern role-based training matrix to demonstrate compliance. Topics of discussion include:
- Organizing your training plans that deliver maximum efficiency;
- Creating a training plan that supports the varying learning needs of your organization; and
- Aligning the right content with the right people at the right time to improve learning outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Christian Torstensson, Director of Learning and Development, Sanofi; Nicole Donovan, Director of Organizational Development, Tolmar; John Constantine, SVP, Orchestrall Inc.; and Kent Malmros, Sr. Director, Vault Training, Veeva Systems
Recorded on: Feb. 16, 2023
Description: David L. Chesney explains everything you need to know about inspection management so you’ll be prepared when the FDA arrives. He shares:
- What the FDA must do to conduct an inspection lawfully;
- What the FDA may not do — by law — during an inspection;
- What an FDA Form 483 is and what may trigger its issuance, plus how to respond effectively if you receive one; and
- The enforcement options the FDA can use and the risks each present to your company.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David L. Chesney, Principal and General Manager, DL Chesney Consulting