How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides proper documentation.
Why You Should Attend:
Your failure to understand and properly respond to a 483 issued to you at the conclusion of an FDA inspection may quickly lead to an administrative or a legal action that can have an immediate adverse effect on a firm’s business.
Areas Covered in the Session:
What the 483 means
How to interpret the 483 - "How bad is it?"
Managing the 483 discussion with the FDA at the conclusion of the inspection
Responding to the FDA in writing
Who Will Benefit:
Regulatory Affairs Managers
Quality Assurance Staff
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” 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 an Associate Center Director for the Center for Devices and Radiological Health.