The Webinar Training Pass

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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.

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!

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Webinar Training Pass

Recorded on: Oct. 18, 2018

Description: Metrics experts Linda Sullivan and Keith Dorricott discuss approaches trial sponsors are taking to comply with ICH E6(R2). They cover:

  • New risk-based quality management requirements described in ICH E6(R2) section 5.0;
  • The importance of critical thinking in risk assessment and risk control;
  • The meaning of high and low detectability and the relevance to risk prioritization; and
  • Leading practices to improve risk assessment and quality oversight.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Linda Sullivan, Executive Director, Metrics Champion Consortium, and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.

Recorded on: Oct. 18, 2018

Description: FDA compliance expert Ricki Chase digs into the details of the CDER revamp and explains how it could affect drugmakers. She discusses:

  • How the Office of New Drugs is organized now and how it will change;
  • What the FDA says is the goal of restructuring, and opportunities and challenges that could result;
  • The specific impact on new drug application reviews; and
  • How the restructuring may affect critical CDER and FDA functions.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Ricki A. Chase, Director, Compliance Practice, Lachman Consultant Services Inc.

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  • The FDA’s latest draft guidance on quality metrics; and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