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: Sept. 15, 2020
Description: Clinical trial data specialist Ken Lownie shares key insights from Agatha Life Science’s State of Remote Monitoring survey. He discusses:
- The imperatives driving remote monitoring as a practice;
- Understanding the technology alternatives; and
- Calculating the costs and savings of remote monitoring.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ken Lownie, Head of North American Operations, Agatha Life Sciences
Recorded on: Sept. 10, 2020
Description: A team of life sciences regulatory experts explores the expanded access terrain, provides an update on current regulatory changes and addresses possible policy solutions. Topics include:
- The existing legal and regulatory landscape driving expanded access;
- Recent congressional changes and how the FDA is implementing those changes;
- The FDA’s voluntary efforts to increase use of expanded access; and
- Policy considerations underlying the expanded access debate, such as monitoring and tracking of expanded access outcomes and adverse events.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: David Farber, Lisa Dwyer and Preeya Pinto, Partners, King & Spaulding
Recorded on: Aug. 20, 2020
Description: Device regulatory expert Dan O’Leary explains the new harmonized coding system and form for adverse event reporting. He covers:
- The code set structures;
- Planned changes to the FDA’s reporting form;
- The relationship between the IMDRF codes and the current FDA codes; and
- The EU Manufacturer’s Incident Report (MIR) and the IMDRF codes it uses.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Aug. 20, 2020
Description: A panel of quality experts discusses a practical approach to harmonizing quality processes that help accelerate technology implementation and adoption. Topics include:
- A proven framework for harmonizing business processes;
- Guidance on navigating complex organizations to gain support; and
- Best practices for transforming quality management systems.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Paola DePaso, Director, Vault Quality, Veeva Systems; Jan Paul Zonnenberg, Partner, Pharmaceutical & Life Sciences Companies, PwC; Anastasia Wengrowski, Manager, Vault Quality, Veeva Systems; and Vishaka Rajaram, Director, Pharmaceutical & Life Sciences Companies, PwC
Recorded on: Aug. 19, 2020
Description: Microbial control expert Jim Polarine shares tips on how to best design a risk-based cleaning program during this global health crisis. He discusses:
- Industry trends;
- Global regulatory expectations; and
- Frequency of cleaning and disinfecting.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation
Recorded on: Aug. 13, 2020
Description: Data analytics experts Mary Jo Lamberti and Francis Kendall discuss primary uses of real-world data (RWD) to generate evidence. They cover:
- Types of technology used to access or collect RWD;
- Significant challenges to using RWD as well as strategies and practices that impact return on investment or performance; and
- Regulators’ position regarding COVID-19 studies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mary Jo Lamberti, Professor, Tufts University, and Francis Kendall, Senior Director, Cytel
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