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: Nov. 16, 2017

Description: A panel of experts discusses the regulatory outlook for drugmakers under the current administration. They cover:

  • Gottlieb’s big-picture approach to drug development;
  • Making the clinical end of drug development more efficient and effective;
  • Integrating real-world evidence in clinical and regulatory decisions; and
  • Initiatives to combat the opioid epidemic.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Douglas W. Balogh, Director, Navigant; Kevin Madagan, Partner, Reed Smith

Recorded on: Nov. 15, 2017

Description: Veeva Vice President Melonie Warfel and Solution Consultant Richard Chu discuss using systems that improve manufacturing processes without risking compliance pitfalls. They cover:

  • Managing, finding, and sharing critical content to enable internal and external collaboration with all critical stakeholders;
  • Providing real-time visibility into documents and processes, and gaining complete control over audits and inspections; and
  • Monitoring and reporting to mitigate compliance risks.

The webinar also includes a demonstration of Veeva’s Vault Suite.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Melonie Warfel, Vice President, Global Medical Device & Diagnostics, and Richard Chu, Solution Consultant, Veeva Systems

Recorded on: Nov. 14, 2017

Description: Quality systems expert Dan O’Leary parses two new final guidances on changes to 510(k) devices. He discusses:

  • The FDA’s plans for evaluation of changes;
  • Role of risk management (ISO 14971:2007) in the evaluation process; and
  • How to establish the quality record to support your decision.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises LLC

Recorded on: Nov. 8, 2017

Description: Device industry veteran Jon Speer discusses best practices for CAPA processes. He covers:

  • How to avoid the most common problems with CAPA;
  • How CAPA connects to other QMS processes; and
  • The impact of risk management on CAPA.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jon Speer, Founder and VP of QA/RA, Greenlight Guru

Recorded on: Nov. 7, 2017

Description: Regulatory expert Tim Hunter presents a model for reimbursement integration designed to increase commercial success. He discusses:

  • How to turn FDA-required data into an argument for health economics;
  • How your FDA negotiations will impact your market; and
  • How to evaluate reimbursement needs vs. regulatory or clinical requirements.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tim Hunter, Vice President, Musculoskeletal Clinical Regulatory Advisers, LLC

Recorded on: Oct. 31, 2017

Description: Regulatory expert David Rosen discusses how principal investigators and sponsors can develop a strategy for dealing with FDA inspections. He covers:

  • How BIMO inspections are started and conducted;
  • What the BIMO team is looking for in terms of following proper protocols for patient recruitment;
  • FDA-recommended best practices in execution of consent forms; and
  • Whether patient volunteers are actually eligible participants in a clinical trial.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Rosen, Partner, Foley & Lardner LLP

Recorded on: Oct. 30, 2017

Description: Quality assurance expert Susan Leister outlines the risk management requirements in the latest revision of ICH E6 – Good Clinical Practice. She discusses:

  • Specific challenge areas: sponsor quality management system, software validation, risk management;
  • The hidden implications of certain changes; and
  • How to achieve full and effective compliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Leister, Director of Quality Assurance, Technical Resources International

Recorded on: Oct. 27, 2017

Description: Supplier contract specialist Courtney Stevens walks you through the essentials of supply contracts. She covers:

  • How to approach a contract negotiation;
  • What every contract must include;
  • Insurance clauses and certificates of insurance; and
  • Audit provisions for further protection.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Courtney Stevens, Senior Attorney-Risk Management and Loss Control, MedMarc Insurance Group

Recorded on: Oct. 25, 2017

Description: A panel of digital innovation experts discusses the potential benefits and pitfalls of leveraging connected devices to respond to the changing healthcare industry. They cover:

  • How the medical device industry can apply IoMT and outcome-based models to achieve patient well-care;
  • What medical device companies are already doing to compete in a new ecosystem that includes at-home patient monitoring;
  • How integrated technology solutions close the loop from ideation through postmarket surveillance; and
  • How cybersecurity threats are being mitigated.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Sandra Rodriguez, Market Analyst, Axendia; Jordan Reynolds, Senior Manager, Kalypso; David Wolf, Senior Manager, Kalypso

Recorded on: Oct. 24, 2017

Description: Organizer and chair of the 2017 Expanded Access Drug Summit Jess Rabourn explains the new proposed best practices for integrating cohort Expanded Access into the drug development process. He discusses:

  • Preapproval access requirements, including key provisions on cost recovery;
  • Prevailing business practices for sponsoring Expanded Access programs; and
  • Capturing real-world evidence and the differentiating factors of treatment response.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jess Rabourn, Founder, WideTrial