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: Sept. 22, 2021
Description: Discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval, including:
- FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
- Determining spreadsheet validation gaps the FDA targets;
- Choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
- Generating spreadsheet specifications and qualification protocols.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance Limited
Recorded on: Sept. 21, 2021
Description: Kristin Davenport and Rujul Desai, both of counsel at Covington & Burling LLP, will share what you must know and do to get your devices included in the FDA’s Breakthrough Devices Program and Safer Technologies Program (STeP) for Medical Devices, explaining:
- STeP and breakthrough criteria, including the submission timing and content requirements for obtaining a breakthrough designation or inclusion into STeP;
- Benefits of breakthrough designation and inclusion into STeP, including expediting approval time; and
- Pathway for nationwide coverage of breakthrough devices, and its impact on your device development program.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kristin Davenport, Of Counsel, Covington & Burling LLP; and Rujul Desai, Of Counsel, Covington & Burling LLP
Recorded on: Sept. 15, 2021
Description: This webinar explains how Agios Pharmaceutical and eClincial Solutions worked collaboratively to build a new system that provides operational data insight and automation of previously manual tasks. They’ll discuss:
- Why existing CTMS are not optimized for companies working in highly outsourced models;
- What are the different options available to companies evaluating CTMS-like technology solutions; and
- How and why Agios Pharmaceuticals selected a partnership approach to find a “right-sized” CTMS data and analytics platform.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Avery McMurray, Manager, Agios Pharmaceutical; and Rob Musterer, Head of eClinical Product Management Team
Recorded on: Aug. 26, 2021
Description: Supply chain disruptions along with new and pending regulations have only increased the pressure. Medical device and diagnostic (MD&D) companies must make big changes or risk noncompliance. This webinar explains how to do just that, covering:
- Changes you must make to the way your products are manufactured and serviced to stay compliant;
- Drivers of change – robotics, healthcare policy, consumer access; and
- Acceleration of digital implementation due to COVID-19.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cris Salinas, Medtech Strategy, Salesforce; Prashanth Rajendran, ComplianceQuest CEO; and Dik Hoogmoed, Director, QA/RA, Canon Medical Systems Europe
Recorded on: Aug. 16, 2021
Description: Sue Marchant, director of product, machine learning and artificial intelligence (AI) at MasterControl, will detail how the technology can investigate corrective and preventative actions (CAPAs) with minimal human involvement and pinpoint the root causes of common complaints. She’ll cover:
- What data is needed to feed an AI system and where to find it;
- Using AI to identify risk and optimize manufacturing;
- How to get corporate management buy-in and implement an AI system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sue Marchant, Director of Product, Machine Learning and Artificial Intelligence, MasterControl
Recorded on: Aug. 12, 2021
Description: Regulatory compliance experts share insights on the likely structure of blended on-site and virtual inspections and audits — and explore ways to merge these best practices to develop an efficient, effective model — covering:
- Virtual audit practices;
- On-site audit practices; and
- Models for post-pandemic audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Steven Lynn, Executive Vice President, Pharmaceutical, Regulatory Compliance Associates Inc; Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance Associates Inc; and Susan Schniepp, Distinguished Fellow,Regulatory Compliance Associates Inc.
Recorded on: Aug. 5, 2021
Description: Amanda McFarland, a QRM and microbiology senior consultant with ValSource, Inc., clarifies the regulations relative to risk management and how to apply the principles of QRM, sharing:
- Best practices related to QRM program development and execution, including process, people and documentation;
- Ways to integrate QRM into your quality systems such as change control and investigations and how integration can benefit your organization; and
- The PIC/S Aide-Memoire on QRM and how you can prepare for a QRM program inspection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Amanda McFarland, QRM and Microbiology Senior Consultant with ValSource, Inc.
Recorded on: July 27, 2021
Description: Learn how manufacturers transformed their quality processes with a modern cloud solution and achieving increased speed, reduced costs and driving seamless collaboration across partners, suppliers and customers. The speakers will discuss:
- Top considerations for evaluating quality cloud solutions;
- Key benefits for manufacturers, partners, suppliers and customers; and
- Lessons learned across evaluation, implementation and adoption.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Sandra Rodriguez, Senior Industry Analyst, Axendia and Ashley Wentworth, Director, Vault Quality, Veeva Systems
Recorded on: July 22, 2021
Description: Wayne L. Pines, president of healthcare at APCO and former associate commissioner of the FDA, leads an expert team that explains what the first six months of the Biden administration have brought and what to expect going forward, including the answers to:
- What is likely to change at the FDA under Biden that will affect what you do every day?
- How should you plan now for upcoming changes to be ready for developments later in 2021 and in 2022 in drug and device regulation, enforcement, drug pricing and health care innovation?
- What new guidances are likely to be issued later this year?
- Who are the key personnel in Biden’s FDA?
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, Member of APCO Worldwide’s International Advisory Council and President of Health Care for the consultancy; Marc Scheineson, Partner, Alston & Bird LLP; Andrea Chamblee, Senior Counsel, Wilson Sonsini Goodrich & Rosati; Allison Fulton, Partner, Sheppard Mullin Richert & Hampton; and Kellie Combs, Partner, Ropes & Gray LLP
Recorded on: July 21, 2021
Description: MDR and IVDR expert Sundeep Agarwal explains how devicemakers creating in vitro devices will need to move forward with the shift from IVDD to IVDR before the implementation deadline, from software considerations to understanding authorized representatives, including:
- Key changes arising from IVDR;
- Details around certifications and evaluations;
- The benefits of quality management systems;
- Supply chains and subcontractors; and
- Preparing for audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sundeep Agarwal, Consultant, Datt Mediproducts