Spotlight on Science Meetings, Conferences and Events brings you information on the following event: Webinar on Managing the FDA form 483: Inspection Observations
This webinar is a complete guide on how to manage the FDA’s 483 observations during and after an inspection. How you respond can make or break you.
Form FDA 483 is a list of observations made by FDA during an inspection. Observations are not a good thing. At the conclusion of an inspection, the FDA investigator lists specific examples that demonstrate an apparent violation of the applicable FDA regulations. You and the FDA investigator will discuss what the investigator found. At that point you are put on notice about your problems. The FDA, such as levying civil money penalties, seizure, injunction, and/or prosecution, warns you that if you fail to correct the problems, it may result in further action.
Firms are well advised to take the written 483 observations and FDA’s verbal warning seriously. A failure to promptly respond in writing to the FDA makes the situation even worse. As an immediate business consequence, marketing departments should expect competitors to show customers your 483. Your 483 is used against you as a bad report.
Areas to be Covered:
- What the Form FDA “483” means
- How to manage the FDA’s 483 observations during and after an inspection
- What the FDA considers important
- How to respond effectively to 483 observations
- Planning for other problems
- Learn how to manage your regulatory profile with the FDA
This seminar is presented by Casper Uldriks, who brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health.
This is an online seminar.
Mississauga, Ontario
https://compliancetrainings.com/product/managing-the-fda-form-483-inspection-observations-4/
Tuesday, May 12, 2015
