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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Webinar Training Pass
Recorded on: Oct. 17, 2018
Description: Quality metrics experts Steven Mendivil and Denyse Baker explain the latest developments in the FDA’s quality metrics plans. They discuss:
- How the agency’s site visit pilot program is progressing and what the FDA has learned so far;
- How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel;
- The FDA’s latest draft guidance on quality metrics; and
- Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Steven Mendivil, Senior Advisor for Quality/External Affairs, Amgen, and Denyse Baker, Senior Policy Director-U.S. Regulatory Affairs, AstraZeneca
Recorded on: Oct. 16, 2018
Description: Regulatory expert Karla Palmer explains the FDA’s 2018 Compounding Priorities Plan. She discusses:
- How sections Secs. 503A and 503B of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities;
- Changes brought about in FDA draft and final guidances;
- What enforcement actions FDA has taken against compounders to date and what could lie down the road; and
- The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Karla Palmer, Director, Hyman Phelps & McNamara P.C.
Recorded on: Sept. 27, 2018
Description: Safety reporting experts Kendra Hayden and Steven Beales point out new efficiencies in safety reporting that can help cut trial costs. They discuss:
- How to reduce a site’s reporting burden by 10 hours per week;
- Global safety reporting regulations; and
- How to maximize control over global safety reporting.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kendra Hayden, Business Transformation Program Lead for Safety Reporting, WIRB-Copernicus Group, and Steven Beales, senior VP-IT and Market Owner of Safety Solutions at ePharmaSolutions
Recorded on: Sept. 25, 2018
Description: Attorney Kelliann Payne, a specialist in medical device regulation, explains the advantages and challenges of using the de novo pathway to device approval. She discusses:
- The differences in regulatory pathways for more novel devices;
- FDA timelines for clearance or approval of novel medical devices;
- Benefits of the pre-submission process for devices seeking de novo classification; and
- Potential pitfalls in the FDA clearance and approval process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kelliann Payne, Counsel, Hogan Lovells
Recorded on: Sept. 19, 2018
Description: Regulatory expert Dan O’Leary breaks down requirements for developing software for use in or with medical devices. He discusses:
- FDA guidance documents related to software;
- Interrelationships among software development, premarket submissions and postmarket activities;
- The role of ISO 14971:2007 as the overarching risk management standard;
- IEC 62304:2006 and its role as a software process standard; and
- How to determine the software safety class of a medical device.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Sept. 17, 2018
Description: Regulatory experts August Horvath and Mark Mansour discuss the variety of federal, state and local authorities keeping an eye on drug and medical device promotion. They cover:
- What to expect from the FDA, FTC, state attorneys general, the Better Business Bureau and others;
- Trigger points for enforcement for each agency;
- How to avoid legal liability; and
- Top tips for remedying enforcement problems.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: August T. Horvath and Mark Mansour, Partners, Foley Hoag LLP
Recorded on: Sept. 12, 2018
Description: Quality management expert Steve McCarthy explains the benefits of leveraging data to improve systems. He discusses:
- The companywide benefits of data-driven quality management;
- Identifying and influencing key stakeholders across the value chain; and
- Creating a foundation for complete, accurate and actionable data.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steve McCarthy, VP of Digital Innovation, Sparta Systems
Recorded on: Sept. 12, 2018
Description: Supply chain management expert Richard Sena discusses how to use supplier quality metrics to evaluate performance. He covers:
- Acceptance percentage v. process yield;
- Training recordkeeping and analysis for self and suppliers;
- Audit preparation and post-audit efficiency; and
- Recall effectiveness measures within the distribution process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Richard A. Sena, Managing Director, Vaquero Canyon Advisors LLC
Recorded on: Aug. 23, 2018
Description: A panel of clinical trial experts discusses the implications and opportunities presented by the developing field of gene therapy. They talk about:
- How genetic testing is being used in clinical trials;
- How precision medicine is making trial protocols more complicated; and
- Expertise and infrastructure needed to collect genetic information.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group; Jill Johnston, President, Site Support & Management for Clinical Services, WCG; Karmen Trzupek, Director of Clinical Trial Services and Director of Ocular and Rare Disease Programs, InformedDNA
Recorded on: Aug. 22, 2018
Description: Attorneys Mark Levy and Elizabeth Abrams discuss potential criminal and civil liabilities drug and device manufacturers often face and how to handle them. They cover:
- Justice Deptartment policy on compliance programs, a process that has direct impact on regulatory and quality professionals;
- Enforcement of the FDCA and the False Claims Act and the impact of whistleblowers; and
- Strategies for avoiding both criminal and civil liability.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mark Levy, Partner, Eckert Seamans Cherin & Mellott; and Elizabeth Abrams, Assistant U.S. Attorney for the Eastern District of Pennsylvania, Criminal Division