483 Covers a Broad Gradation of Problems

Overview:
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:
Manufacturers
FDA Consultants
Legal Counsel
Regulatory Affairs Managers
Quality Assurance Staff

Speaker Profile:
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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]