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: Feb. 8, 2018

Description: Regenerative medicine expert Andrew Ittleman explains how the FDA’s regulation of stem cell and HCT/P use is evolving. He discusses:

  • How the FDA is interpreting “homologous use,” “minimal manipulation” and “same surgical procedure;”
  • Parameters of the FDA’s 36-month enforcement discretion policy;
  • The FDA’s new RMAT pathway; and
  • Regulation of devices commonly used in regenerative medicine.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Andrew Ittleman, Partner, Fuerst Ittleman David & Joseph PL

Recorded on: Jan. 31, 2018

Description: Quality assurance expert Susan Schniepp explains how to put together a strong internal audit team that can spot issues and deal with them before they become problems. She discusses:

  • Better utilizing internal audit observations to drive continual improvement and remediate shortcomings;
  • Qualities of effective auditors and team leaders; and
  • Good documentation practices — the best prevention against warning letters and other regulatory headaches.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.

Recorded on: Jan. 31, 2018

Description: Combination products expert Angela Pitwood interprets the FDA’s final rule on post-approval safety and reporting for combination products. She discusses:

  • Who on the product safety staff should have the responsibility for combination product safety and reporting;
  • How to avoid receiving FDA warning letters on combination product reporting and safety; and
  • How to implement real-world best practices for safety reporting.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Angela Pitwood, Vice President of Pharmacovigilance, Vigilare

Recorded on: Jan. 30, 2018

Description: Attorney Michael Gaba discusses the FDA’s evolving view of consumer health products under the 21st Century Cures Act. He covers:

  • How the Cures Act may set new limits on the FDA’s authority by redefining “medical device” to exclude significant software functions;
  • What the agency must do to harmonize its guidance with current law and how this could affect devicemakers’ regulatory decision-making in the interim; and
  • The urgent need to re-evaluate existing and planned products that make health and wellness claims.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Michael M. Gaba, Vice Chair, FDA Practice Group, Polsinelli PC

Recorded on: Jan. 26, 2018

Description: Lean Six Sigma expert Miguel Guerrero discusses using lean management principles to improve quality, ensure compliance and boost profit. Topics include:

  • Identifying value and mapping the value stream;
  • Input Control Templates, a means to reduce or end rework on processes; and
  • The “Poke Yoke,” a way of slashing errors in development processes.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Miguel Guerrero, Managing Director and Principal, Synergis

Recorded on: Jan. 25, 2018

Description: Clinical trial contracting experts Suzanne Caruso and Brooke Millman discuss negotiating and finalizing site contracts to ensure that you begin your next study holding all the cards: quick startup, decreased costs, no unnecessary terms and conditions that cause hassles and delays. They cover:

  • Start-up dates, deadlines, and schedules;
  • Necessary and avoidable costs and expenses;
  • Air-tight provisions that avoid hassles and complications;
  • Enrolling patients to expedite trials and time to market; and
  • Payment terms and conditions that meet your budget.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Suzanne Caruso, Vice President , Clinical Solutions, and Brooke Millman, Vice President, Consulting Solutions, WIRB Copernicus Group

Recorded on: Jan. 24, 2018

Description: Attorneys Naomi Halpern and Georgia C. Ravits discuss the intersection of social media and FDA regulation in advertising and promotion. They cover:

  • Common social media mistakes that trigger warning letters;
  • How to deal with misleading, untruthful and/or biased posts;
  • Use of social media for adverse event reporting and product improvement; and
  • Likely FDA moves that could affect your use of social media.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Naomi J.L. Halpern, Counsel, and Georgia C. Ravitz, Senior Partner, Arent Fox LLP

Recorded on: Jan. 18, 2018

Description: Quality systems expert Dan O’Leary presents a step-by-step guide to the FDA’s requirements for calibrating medical devices. He covers:

  • The role of monitoring and measuring in a medical device quality management system;
  • The FDA and international requirements for calibration;
  • The distinction between “accuracy” and “precision;” and
  • The role of traceability in a calibration program.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Jan. 17, 2018

Description: China regulatory expert Grace Fu Palma presents tips for preparing IVD premarket submissions to China’s food and drug authority. She covers:

  • CFDA IVD registration requirements and how they differ from FDA classifications;
  • How to prepare samples to pass local IVD approval tests;
  • Changes in the clinical trial exemption catalog; and
  • Changes in CFDA medical device supervision and monitoring in regard to registration of legal agents.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Grace Fu Palma, CEO, China Med Device LLC

Recorded on: Jan. 9, 2018

Description: Quality management expert Chris Thornton discusses cutting-edge ways to use digital technology for streamlining quality processes, consolidating systems, achieving full compliance and managing risk. He covers:

  • The impact Industry 4.0 and Internet of Things (IoT) has on the quality ecosystem;
  • Benefits and challenges of using cloud platforms and other digital innovations in the GXP-regulated environment; and
  • Augmenting quality strategy with cloud technology.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Chris Thornton, Director, Global Accounts, Sparta Systems