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: 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
Recorded on: July 14, 2021
Description: Michael Meighu, PhD — a life science specialist with more than 20 years of experience in the field, focusing on AI and data science — translates AI and machine learning (ML), sharing:
- What natural language processing (NLP) is and how it can help you;
- An understanding of neural networks and deep learning and how you can put them to use;
- What AI open source is and how can it assist in developing prototypes or proof of concepts in the medical product space; and
- An understanding of python and fast.ai toolkits and ways to incorporate them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael Meighu, PhD, Life Science Specialist and Justo Rodriguez, PhD, Data Scientist
Recorded on: July 13, 2021
Description: Greenleaf Health, Inc. experts share how to implement strategic engagement and planning and develop a quality and compliance strategy that aligns with CBER’s regulatory expectations, explaining:
- The relevance of CBER’s four overarching goals for FY 2021-2025;
- What you must understand about CBER’s four priorities that will inform its policy decisions for the next five years; and
- An analysis of the role CGT and personalized medicine development, advanced manufacturing technologies and AI/ML, RWE and RWD will play in CBER’s strategic and regulatory activities.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.; Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc.; and Kate Cook, Principal, Regulatory Policy, Greenleaf Health, Inc.
Recorded on: July 13, 2021
Description: SoftServe experts provide a fundamental framework for setting up and scaling the digital technologies your need to successfully engage patients remotely and safely generate and protect participant data. This webinar covers:
- The increased need for and benefits of decentralized trials;
- Improved data and privacy;
- How to avoid costly consequences of unsuccessful trials; and
- Ways to incorporate digital technology.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Steve LoSardo, Vice President, Life Science Solutions and Consulting, SoftServe; and Mariya Boychuk, Senior Business Analyst for Healthcare Solutions, SoftServe
Recorded on: July 8, 2021
Description: Using real-world lessons from companies who have already gone through the process, this webinar will provide you with a detailed understanding of the EU-MDR requirements and regulations, including:
- What to know about expected challenges during the transition;
- Where to focus and prioritize in the EU-MDR certification process;
- Coordinating and planning around your Notified Body; and
- Balancing the Technical file and QMS audit review.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Linda L. S. Lovett, CEO of Lovett Consulting