Simplifying Global Compliance
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. 22, 2018
Description: Quality systems expert Dan O’Leary explains his supplier metrics system, which includes determining your expectations of the supplier, converting them into measurable characteristics, defining the measurement method, and setting the target. He discusses:
- Requirements from ISO 13485:2016 and additional guidance from the ISO 13485:2016 Handbook;
- Inspection tasks from the FDA’s QSIT;
- Audit tasks from the MDSAP Audit Model;
- Incorporating predictive metrics; and
- Markers of poor performance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Feb. 22, 2018
Description: Clinical trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment. They cover:
- The five stages of recruitment;
- Recruitment problems that can stem from lack of time; and
- Benefits of a community recruitment strategy.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kari Lotsberg, Manager of Site Services, ThreeWire and Fabian Sandoval, CEO & Research Director, Emerson Clinical Research Institute
Recorded on: Feb. 21, 2018
Description: Product development specialists Julie Tibbets and Alexander Varond outline strategies for easing the drug approval process. They discuss:
- 21st Century Cures Act implementation update, including FDA guidance development;
- The latest FDA approval pathways — fast track, breakthrough therapy, accelerated approval and priority review; and
- Aligning R&D with regulatory approval pathways.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Julie Tibbets, FDA Partner in the Technology & Life Sciences Group, and Alexander Varond, Senior Associate, Goodwin Procter LLP
Recorded on: Feb. 20, 2018
Description: Patient recruitment experts David Borasky and Amanda Plucinak present strategies for expediting study recruitment. They discuss:
- How to develop data to understand why studies are behind schedule and over-budget;
- How to use proven strategies and tactics to improve your patient recruitment numbers;
- How to foster awareness of the importance of implementing appropriate effort into creating a recruitment plan for a study; and
- How to comply with new GDPR requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: David Borasky, Vice President, IRB Compliance, WIRB-Copernicus Group and Amanda Plucinak, Quality Assurance Manager, ThreeWire
Recorded on: Feb. 15, 2018
Description: A panel of clinical research experts discusses the challenges of setting endpoints in studies of rare and orphan diseases in the neurodevelopment space. Topics include:
- Measuring change in core and associated behaviors in autism spectrum disorder;
- Adapting the CGI Scale for developmental disabilities; and
- Applying the old clinical trial model to a new medical research environment.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Brian Rothman, Vice President of Clinical Services, MedAvante-ProPhase; Gahan Pandina, Senior Director and Venture Leader, Janssen Research and Development; Abi Bangerter, Clinical Research Manager, Janssen Research and Development; Michael Aman, Professor Emeritus of Psychology, The Ohio State University; and Mark Opler, Chief Research Officer, MedAvante-ProPhase.
Recorded on: Feb. 14, 2018
Description: Former CDRH Associate Director for Policy Paul Gadiock explains the center’s new total product lifecycle approach that feeds postmarket observations back into premarket data requirements. He discusses:
- The right office to contact after the reorganization;
- The right way to frame your case and make the most persuasive argument;
- Lessons learned from similar reorganizations at CDER and CDRH/OIR; and
- How reorganization may affect CDRH interplay with other FDA bureaus.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Paul Gadiock, Senior Attorney, Arent Fox LLP
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