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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
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
Recorded on: Dec. 20, 2017
Description: Device expert Thomas Shook discusses how the use of wearable devices and sensors can impact the world of clinical trials. He covers:
- Best practices in use of sensors and wearables, including subject protection and data privacy;
- How mHealth is changing data collection in clinical trials;
- New types of health information now collectible with sensors; and
- The regulatory impact of sensors and wearables.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Thomas Shook, Executive Vice President and Senior Medical Officer, PAREXEL
Recorded on: Dec. 14, 2017
Description: A panel of industry experts discusses the FDA’s plans and priorities for 2018 and beyond. They cover:
- Opioids;
- The new drug approval process;
- FDA transparency; and
- Orphan drugs and rare diseases.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Steven Grossman, President, HPS Group, LLC; and Brian E. Harvey, Principal Consultant, Brian E Harvey LLC
Recorded on: Dec. 6, 2017
Description: Device development expert Anthony Parise explains how to use risk management tools to secure your supply chain. He discusses:
- How risk management tools can open new windows into compliance;
- Leveraging risk in compliance, product performance and safety;
- Risk management tools your competitors are using; and
- Turning suppliers into compliance and quality partners.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Anthony Parise, Life Sciences Product Strategist, Verse Solutions