The Webinar Training Pass

Now get all the training you need – all in one place, and all for one low price!

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.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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.

Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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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

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

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

Transcript: Download the transcript

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