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. 6, 2020
Description: Recall expert Ginger Glaser describes potential recall issues and explains how to upgrade your plan and improve your decisionmaking. She covers:
- An overview of FDA requirements for recalls of medical devices, analysis of guidelines and development of a recall strategy;
- Definitions of corrections vs. removals;
- Potential impacts of recalls or corrective actions in one or more geographical areas as part of a global business; and
- Examples of various recall situations and the specific strategy elements that ought to be considered.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ginger Glaser, Chief Technology Officer, Monteris Medical
Recorded on: Aug. 5, 2020
Description: Compliance expert Ricki Chase discusses the impact on the drug supply chain and what a post-COVID world might look like, including the regulation changes coming from the FDA and other regulators. She covers:
- The impact on FDA approvals for COVID-19 drugs and other pharmaceuticals and how the FDA will recover and move these forward post-COVID;
- The effect on postmarket surveillance and options for FDA to move this forward;
- Modifications of clinical expectations and implications for post-COVID operations, including what it might mean for recruitment and operation of clinical trials; and
- Emergency Use Authorizations (EUAs) and their significance to the market after the EUA is lifted.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ricki Chase, Executive Director, Lachman Consulting Services, Inc.
Recorded on: July 30, 2020
Description: Blockchain technology specialist James Canterbury explains the core tenets of distributed systems, blockchains and cryptography in quality and compliance processes. He discusses:
- Where blockchains are currently being used in the pharmaceutical industry, including manufacturing and the supply chain;
- The core components of blockchain technology, including single-source data integrity;
- Public vs. private blockchains and the challenges, advantages and disadvantages of each; and
- How to use a blockchain as a notarization system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Canterbury, Partner, Ernst & Young
Recorded on: July 29, 2020
Description: UDI expert Jay Crowley shares ways to manage multiple regulatory bodies, best practices around establishing and maintaining robust and effective global UDI processes, possible responses to distinct local UDI concerns and how to submit identification product data to various stakeholders. Topics include:
- The evolution of UDI guidelines;
- Intertwining regulatory, commercial and patient safety information;
- Initial development, maintenance and reuse of information; and
- EU UDI requirements, including EUDAMED expectations.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jay Crowley, Vice President, Unique Device Identification Solutions and Services, USDM Life Sciences
Recorded on: July 29, 2020
Description: Risk management expert Amanda McFarland discusses applying risk-based quality management decisionmaking to ensure the long-term impacts of your company’s current decisions are fully understood. She covers:
- Ways to integrate risk management into your quality systems;
- The PIC/S Aide-Memoire on quality risk management and how to prepare for an inspection; and
- Risk management tools available, such as process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP) and FMEA.
Presentation: Download the presentation
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Speaker: Amanda McFarland, QRM and Microbiology Senior Consultant, ValSource
Recorded on: July 23, 2020
Description: Clinical trial privacy experts Sarah Lyons and Vivien Fagan explain how to build brand trust through clinical trial transparency, navigate evolving transparency regulations and protect patient privacy when sharing clinical trial data. They discuss:
- Current transparency requirements for study publication from the FDA, EMA and Health Canada;
- The link between transparency, privacy and brand trust, and how privacy-preserving data-sharing methods can help sponsors earn trust with internal and external stakeholders, including patients themselves;
- Best practices for anonymization to enable trial transparency while protecting participant privacy, including quantitative re-identification risk measurement; and
- Preserving data utility and protect patients when sharing data voluntarily.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Sarah Lyons, General Manager of Privacy Analytics, and Vivien Fagan, Director of Medical Writing and Clinical Trial Disclosure, IQVIA
Recorded on: July 22, 2020
Description: Regulatory expert Scott Burger presents best practices for determining the necessary level of comparability studies, planning and preparing for analysis, and avoiding common mistakes in a package for the FDA. He covers:
- Determining the necessary rigor of a comparability study;
- Using the right analytical tools, samples, and statistical analyses;
- In vitro versus in vivo comparability studies; and
- Common mistakes and how to avoid them.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott Burger, Principal, Advanced Cell and Gene Therapy
Recorded on: July 16, 2020
Description: Medical device regulatory expert Dan O’Leary discusses how to meet the technical and regulatory requirements for inspection, measuring and test equipment. He covers:
- Definitions and examples of accuracy, precision and traceability;
- The requirements of FDA QSR and ISO 12485:2016;
- The effective use of quality audits and international quality audit programming; and
- Quality agreements covering outsourced processes.
Presentation: Download the presentation
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Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: July 16, 2020
Description: Learning strategy specialists John Constantine and Kent Malmros discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program. The cover:
- How micro-learning can boost your GxP training compliance;
- How to overcome the common misconceptions about micro-learning; and
- How to implement micro-learning into your GxP training program.
Presentation: Download the presentation
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Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director, Vault Training at Veeva Systems
Recorded on: July 15, 2020
Description: Statistical methods expert Steven Walfish presents tools for developing statistical sampling plans. He covers:
- The differences between confidence and reliability in the sample size;
- Incorporating statistical assumptions, such as independence, as part of all sampling plans; and
- How variance in the population impacts the sample size necessary to establish objective evidence.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Walfish, President, Statistical Outsourcing Services