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483 Covers a Broad Gradation of Problems

 
  August 09, 2017  
     
 
Netzealous LLC DBA - Compliance4All, Online
2017-10-25


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



Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
 
 
Organized by: Event Manager
Invited Speakers:
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.
 
Deadline for Abstracts: 2017-10-24
 
Registration:
Full Details & Registration Link:
E-mail: support@compliance4All.com
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