Simplifying Global Compliance
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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.
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Webinar Training Pass
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
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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
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Speakers: Mark Levy, Partner, Eckert Seamans Cherin & Mellott; and Elizabeth Abrams, Assistant U.S. Attorney for the Eastern District of Pennsylvania, Criminal Division
Recorded on: Aug. 16, 2018
Description: Three FDA specialists weigh in on Commissioner Scott Gottlieb’s first year in office and his priorities for the future. They discuss:
- What Gottlieb is trying to change and how he’s going about making it happen;
- How the drug and device approval process has changed and how it could change in the future; and
- The commissioner’s strategy for dealing with the opioid crisis.
Presentation: Download the presentation
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Speakers: John Kamp, Counsel, Coalition for Healthcare Communication; Kevin Madagan, Partner, Reed Smith; and Wayne Pines, President of Health Care, APCO Worldwide
Recorded on: Aug. 15, 2018
Description: FDA specialist Sonali P. Gunawardhana and clinical research expert Mary Jo Lamberti discuss the evolution of real-world evidence (RWE) in clinical studies and the FDA’s policies and priorities. Topics include:
- Ways drugmakers are using RWE to support promotional claims and premarket applications;
- Impact of recent FDA statements on including RWE in approval and clearance applications and as a basis for drug and device promotional claims; and
- How the agency may use RWE to support regulatory decisionmaking.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP, and Mary Jo Lamberti, Professor and Associate Director of Sponsored Research, Tufts Center for the Study of Drug Development