The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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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.
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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