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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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
Recorded on: March 22, 2022
Description: A panel of FDA inspection experts discusses the current and future state of the agency’s drug/biologics facility inspection activities. Topics include:
- Differences between remote and on-site inspections;
- Requirements for virtual inspection sessions; and
- Preparing for FDA records requests.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cynthia Schnedar, Principal of Regulatory Compliance, Greenleaf Health; Steven J. Lynn, Executive VP of Pharmaceuticals, Regulatory Appliance Associates; Bob Rhoades, Managing Partner, Validant
Recorded on: March 17, 2022
Description: Medical devices expert Seyed Khorashahi discusses a risk-based approach to FDA inspection preparation, including:
- New alternative inspection tools the FDA is using; and
- What FDA investigators will focus on in 2022 and beyond.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Seyed Khorashahi, Executive Vice President of Medical Device and CTO, Regulatory Compliance Associates
Recorded on: March 17, 2022
Description: Quality systems experts Dan Matlis, Sandra Rodriguez and Edward Armstrong, discuss using cloud applications to improve quality management. They address:
- Benefits of digitizing quality systems and documents;
- Good technology practices;
- Barriers to digital transformation; and
- Activities of the FDA’s Office of Digital Transformation.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Dan Matlis, Founder and President, Sandra Rodriguez, Senior Industry Analyst, Axendia; and Edward Armstrong, Director of Quality Assurance, Mustang Bio
Recorded on: Feb. 24, 2022
Description: Quality management experts Nate Henriod and Peter Harris of MasterControl discuss how the FDA has adapted its inspection practices to the pandemic environment and how manufacturers can cope with the changes. They cover:
- The challenges of remote inspections and how digitizing can help solve them;
- Benefits of remote oversight;
- What inspection practices may continue beyond the pandemic; and
- Best practices for managing remote audits and inspections.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Nate Henriod and Peter Harris, Senior Product Managers, MasterControl
Recorded on: Feb. 23, 2022
Description: If one of your biggest pain points right now is the in-bound pharma supply chain, this webinar is for you. It explains how to develop better ways of working that can end the supply chain issues impacting materials availability once and for all and covers:
- Why the improved change control approach is a fit for the needs of the industry and the needs of patients;
- How to implement the Quality by Design and ICH Q12 methods proposed by BioPhorum as part of an approach to the registration of innovative raw materials; and
- How being agile regarding change will alleviate the current situation for the availability of raw materials for your own production and for production across the industry.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Robert Brooks, Phorum Leader, BioPhorum Supply Partner
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
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
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
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
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