FDA Inspections of Medical Device Sponsors Strategies for Compliance
$249.00
Product Details
Medical device sponsors of clinical research received the unwelcome news of the increase in violations from the Center for Devices and Radiological Health’s (CDRH) division of Bioresearch Monitoring (BIMO).
Is this just a coincidence or is it an indication of tough new standards of conduct for clinical trials? Check out the FDA’s website for the current fiscal year and you’ll find out!
What strategies can you take to ensure compliance at your next inspection?
In this 90-minute Encore presentation, Carl Anderson, senior consultant, Biologics Consulting Group, will discuss the specific violations that FDA field investigators are currently citing on Form 483s, inspectional observations and warning letters to medical device sponsors. He’ll detail the proactive steps you can take to ensure a deficiency-free inspection.
Sign up your entire team to listen in and discover:
- The seven most-cited violations during FDA inspections of medical device sponsors
- The five basic recommendations from FDA managers to avoid Form 483s
- What violation has entered FDA’s “Top 5” list for the first time
- A simple tool that documents compliance with FDA sponsor requirements that can be used to prepare both sponsors and clinical investigators for successful FDA inspections