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Event NameACI’s 2017 FDA Boot Camp: Device Edition
Event Date(s) Wednesday, July 26, 2017  to Friday, July 28, 2017
Event Location Wyndham Grand Chicago Riverfront
Chicago, Illinois
Cost$2,095 - $2,295
DescriptionACI’s FDA Boot Camp – Devices Edition has been designed by leading regulatory attorneys to give both regulatory professionals and those who work in conjunction with the medical device industry—such as products liability specialists, in-house counsel, quality affairs, business development executives, and compliance professionals—a strong working knowledge of core FDA competencies.

This year’s FDA Boot Camp-Devices Edition provides both a “basic training” in FDA regulatory law, as well as “advanced training” sessions tailored to the application of this knowledge to real-life situations. Highlights from this year’s program include a “Ripped from the Headlines” panel, containing updates on key developments in the FDA regulatory bar.

A distinguished faculty of top FDA regulatory device experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:

• The organization, jurisdiction, functions, and operations of FDA
• An overview of medical device regulations
• The classification of devices and the concept of “risk-based” classification
• Clinical trials and IDEs
• The 510(k) clearance process – what you need to know now and what to expect in the future
• The premarket approval (PMA) process, device labeling, and promotion
• General post-market controls and MDRs
• QSRs vs. cGMPs and ISO
• Mitigating the impact of enforcement actions
• Recalls, product withdrawals, and FDA’s oversight authority
SponsorRebound Therapeutics
Host CompanyRebound Therapeutics
Contact Information Phone: 212-352-3220 ext. 5291
Fax:   N/A 
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