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 19, 2021
Description: Two members of King & Spalding’s FDA and Life Sciences practice give you an overview of the ASCA pilot, show you how to conform to it and use it to your advantage, explaining:
- Who may participate in the ASCA pilot;
- Pros and cons of participating;
- What participants can expect;
- Implications of the ASCA pilot moving forward; and
- What information is made available on pilot participants.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Quynh Hoang, Senior Regulatory Consultant in the FDA and Life Sciences practice at King & Spalding; and Elaine Tseng, artner in King & Spalding’s nationally recognized FDA and Life Sciences
Recorded on: May 6, 2021
Description: This webinar explains what’s coming, identifies the constraints and power shifts within the biotechnology industry and clarifies how you can adjust now so you can move ahead. You’ll learn:
- What clinical trials will look like after the safety restrictions are lifted;
- Which trends will not survive (but should!); and
- Who will call the shots when trials restart.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Allgood, Product Marketing, Egnyte for Life Sciences
Recorded on: May 5, 2021
Description: Natalie Weber, a quality engineer at MasterControl, Inc., explains the new landscape of remote audits, clarifying:
- How to achieve the same goals during remote audits;remote audits are conducted and what they include;
- Why digitizing is the only way to perform remote audits; and
- Regulators’ attitudes toward remote audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Natalie Weber, Quality Engineer, MasterControl, Inc.
Recorded on: April 21, 2021
Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice explain what can be gleaned from the forthcoming pandemic-influenced guidances impacting drug development, real-world evidence and digital health. They’ll discuss:
- Regulatory framework for biosimilars and possible changes with planned FDA guidance addressing labeling, promotion, interchangeability and exclusivity;
- Drug exclusivity framework and possible changes with planned FDA guidance addressing 180-day exclusivity, pediatric exclusivity and three-year exclusivity;
- Current state of real-world evidence in drug development, key open questions and planned FDA guidance addressing regulatory considerations with the use of real-world data to support FDA decision-making for drugs and biologics; and
- Emerging topics related to drug development and anticipated FDA guidance addressing decentralized clinical trials, substantial evidence and breakthrough therapy designation.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kellie Combs, Partner, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice; and Sarah Blankstein, Senior Associate, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice
Recorded on: April 15, 2021
Description: This webinar will help you determine whether an eTMF system is the right choice for your team. Through expert advice and tips, you’ll gain insights into:
- The five signs of eTMF readiness;
- eTMF features and functions;
- Predictors of eTMF success;
- The time and money savings from an eTMF; and
- Building support for an eTMF initiative.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ken Lownie, Head of North American Operations, Agatha
Recorded on: April 8, 2021
Description: With this webinar, you’ll be able to determine the differences between traditional medical device regulations and software as a medical device (SaMD) regulations. It covers:
- The unique and novel risks software-intensive medical devices pose to the healthcare system;
- Difficulties and benefits that can come from SaMD versus 510(k) compliance;
- How automated RegOps could reduce preparation time for FDA submissions; and
- How building regulatory practices directly into the systems development lifecycle could ease inspection and audit burdens.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Shahid Shah, Founder of Netspective Communications
Recorded on: April 6, 2021
Description: Eric Henry addresses the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory literature, including:
- How cybersecurity relates to design controls and the quality system more generally;
- Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts;
- How addressing cybersecurity risk relates to product risk management; and
- What regulatory literature currently exists globally and some of the ways they compare to each other.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding
Recorded on: March 24, 2021
Description: Tom Comstock presents LNS Research’s latest findings on the intersection of Industrial Transformation (IX) and Quality 4.0 specific to life sciences organizations, including pharmaceutical, biotechnology, medical device and more. He discusses:
- How you can improve your quality monitoring and outcomes;
- Why your data and its analysis are core to both Industrial Transformation IX and Quality 4.0;
- The role of executive leadership in transformation and the quality team as a key business partner; and
- What the leading cause of failure is in meeting your quality objectives and how you can avoid it.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Tom Comstock, Principal Analyst, LNS Research; Stephen McCarthy, Vice President of Digital Innovation, Sparta Systems
Recorded on: March 18, 2021
Description: Cynthia Schnedar ensures that you understand how the FDA conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness. She explains:
- The FDA Adverse Event Reporting System (FAERS) and how the FDA evaluates the information in the database;
- Nuances of the FDA Program Guide CHAPTER 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Program: 7353.001;
- How the FDA uses its MedWatch program to provide information on mandatory reporting by manufacturers; and
- What type of reports a manufacturer must submit to the FDA when deviation from current good manufacturing practice regulations occur.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Cynthia Schnedar, Executive Vice President of Regulatory Compliance, Greenleaf Health
Recorded on: March 18, 2021
Description: Sundeep Agarwal addresses manufacturers’ challenges in designing a compliant AI framework that is safe, effective and beneficial for human health around the world, including:
- Introduction to artificial intelligence (AI);
- Overview of the regulatory framework of AI in the U.S. and EU;
- AI-based software classification; and
- Quality system and good machine learning practices (GMLP).
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sundeep Agarwal, General Manager of Compliance & Regulatory Affairs, Datt Mediproducts, India