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Home » Webinars

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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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BUY NOW Single-User 1-Year Unlimited Access $1,297

Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact James DeFalco, Sales Director at jdefalco@wcgclinical.com or +1 703.538.7638 to receive a custom quote.

Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Webinar Training Pass

Gene & Cell Therapy Regulation: Comparability and Other New Developments
91 minutes

Recorded on: Feb. 17, 2022

Description: If you’re involved in developing gene and cell therapy products, the FDA and other regulators have made it clear: comparability studies are essential to product approval. This webinar explains:

  • FDA requirements for comparability studies for gene and cell therapy products;
  • Best practices for risk analysis and mitigation using comparability studies;
  • How to design an effective comparability protocol for a gene or cell therapy product; and
  • How to construct a statistical approach to comparability.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Scott R. Burger, Principal, Advanced Cell & Gene Therapy; William E. Janssen, Principal, WEJ Cell and Gene Therapy Consulting Services

Statistics and Data for Regulatory Professionals and Attorneys: Product Performance Evidence Made Easy
71 minutes

Recorded on: Feb. 16, 2022

Description: Using the legal and scientific methods he developed over 30 years, Baker & Hostetler partner Lance Shea shares his straightforward framework and methods so you can:

  • Assess the reliability of data, information or evidence and the weight they provide for regulatory or litigation decisions;
  • Evaluate the persuasive strength of such data, information or evidence;
  • Direct the development of evidence to support requests for or responses to regulatory actions; and
  • Guide the advocacy of product performance evidence to address regulatory, litigation and policy issues.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Lance Shea, Partner, Baker Hostetler

Successful Strategies for Digital Health in 2022: Who’s Doing Digital Well and How You Can Get Started
68 minutes

Recorded on: Feb. 15, 2022

Description: Experts Steve LoSardo and Mariya Boychuk explore what you can expect to see in the coming year and provide examples of life science organizations that are managing this growth well. They cover:

  • The impacts of COVID-19 on digital health;
  • What the term “digital health” means;
  • Technology for clinicians, including AI-driven diagnostic tools; and
  • Key factors to consider in building a digital health solution.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Steve LoSardo, Vice President of Life Science Solutions and Consulting, and Mariya Boychuk, Senior Business Analyst, SoftServe

The Biden Administration’s FDA: A Remarkable 2021, What to Expect in 2022
180 minutes

Recorded on: Jan. 20, 2022

Description: This webinar helps answer your biggest questions about new and forthcoming changes to FDA policies and personnel. The panel will discuss:

  • The major FDA issues, challenges and accomplishments of 2021;
  • The priorities for the new FDA commissioner in 2022;
  • The priorities for the FDA medical centers in 2022 as they transition to a new normal; and
  • Provisions to be included in user fee legislation and how they will affect daily business.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Healthcare, APCO Worldwide; Kevin Madagan, Partner, Life Science Health Industry Group, Reed Smith; Nancy Myers, CEO and Founder of Catalyst Healthcare Consulting; Dave Fox, Partner, Hogan Lovells; Jeff Gibbs, Director, Hyman Phelps & McNamara

Enabling Proactive Quality Management Across Quality and Manufacturing
57 minutes

Recorded on: Jan. 20, 2022

Description: Mike Jovanis shares digitization opportunities and proven best practices that will help you drive proactive quality management across quality and manufacturing. You will learn:

  • How digital transformation enables companies to pursue quality excellence;
  • Opportunities to unify and streamline systems and processes; and
  • Best practices from leading companies to enable proactive quality management.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Mike Jovanis, Vice President of the Vault Quality product suite for Veeva

Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
74 minutes

Recorded on: Jan. 13, 2022

Description: Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, explains how to build a quality culture within your organization. She shows you how to:

  • Define the leadership objectives that must be at the root of quality initiatives;
  • Achieve buy-in so that employees accept and adhere to product integrity and ethical standards;
  • Manage product lifecycles, with an open discussion of quality hazards in each stage of business; and
  • Promote — and gain wide acceptance for — collaboration, and how to pick your team.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates

Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review
69 minutes

Recorded on: Jan. 12, 2022

Description: Legal and regulatory experts Kristin Davenport, Rujul Desai and Christina Kuhn detail the avenues that you can take to achieve a successful premarket review from the FDA, including:

  • FDA premarket review pathways;
  • Breakthrough device designation and STeP; and
  • Medical coverage of innovative technology (MCIT) pathway.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Kristin Davenport, of Counsel, Covington & Burling LLP; Rujul Desai, of Counsel, Covington & Burling LLP; and Christina Kuhn, Associate, Covington & Burling LLP

Pharmaceutical Naming Regulation: Understanding the Latest Developments
75 minutes

Recorded on: Jan. 11, 2022

Description: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding is an international leader in preventing medication errors due to brand name confusion. During this webinar she shares:

  • How the prescreening process relates to attributes that may contribute to medication errors in naming drugs;
  • Suggested methods of evaluating the risk of medication errors related to naming;
  • The FDA process for notifying applicants that have similar names in the FDA queue; and
  • The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding

Promoting & Marketing in the Digital and Virtual World: What Regulatory, Compliance & Marketing Professionals Need to Know
91 minutes

Recorded on: Dec. 15, 2021

Description: Explore the legal and regulatory risks that reviewers may spot when assessing marketing materials. You’ll learn about:

  • FDA regulations and guidance related to digital and virtual promotion and marketing tactics;
  • The future of promotions and marketing; and
  • Red flags and risk areas that legal and regulatory reviewers may spot when assessing virtual promotion materials.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Susan Lee, Partner, Goodwin’s Life Sciences Group and FDA Practice; and Elizabeth Mulkey, Senior Associate, Goodwin’s Technology and Life Sciences Group and FDA practice

Extractables and Leachables: Taking a Deeper Dive
84 minutes

Recorded on: Dec. 14, 2021

Description: With this expert advice, you’ll eliminate confusion around defining extractables and leachables and learn to determine which regulatory requirements apply. This webinar covers:

  • The specifics of what constitutes an extractable or leachable;
  • Evaluating USP guidelines and industry standards;
  • How to design an extractable and leachable program that meets your development goals and addresses regulatory requirements; and
  • Frequent analytical challenges associated with extractables and leachables.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kevin Wells, Group Leader, Eurofins BioPharma Product Testing-Columbia

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