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What Every FDA Regulated Company Needs to Know About its FDA District Office

 
  June 20, 2012  
     
 
ComplianceOnline, Online Event
2012-07-18


Why Should You Attend:

Any firm that expects to not have FDA regulatory issues must understand its District office and how the District Office plays such an important role. The FDA implements much of its authority to regulate food and health products for which it is responsible through its 26 district offices. The activities of district offices through inspections and other contacts with firms can well be instrumental in how the firm is regarded by the FDA, with the result that decisions and field laboratories in the Centers and Offices at FDA headquarters may be impacted by recommendations and reports of the district office. FDA views firms it regulates as either “a player” or a “non-player. By having good relations with the FDA District Office a firm will be perceived as a “player.”

Areas Covered in the Seminar:
  • The organization of district offices within FDA regions
  • The responsibilities of FDA District Offices.
  • How District Offices are organized.
  • Why not all District Offices have the same responsibilities.
  • District Offices and FDA laboratories.
  • The relationship between District Offices and the Centers at FDA.
  • How agency politics can impact on FDA”s District Offices.
  • Establishing a good relationship with the District Office.
  • Maintaining a good relationship with the District Office.

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Charles R. (Bob) McConachie, is a Dallas, Tx attorney. He has practiced food and drug law beginning in 1970 at the Department of Justice where he litigated FDA enforcement and regulatory law cases in federal courts. From 1975 to 1979 he served as Chief of the Consumer Affairs Section, now the Consumer Protection Division of the Civil Division at DOJ. Among other cases he personally argued the case in which the FDA's decision to remove Red Dye No. 2 from the market by the end of the day was upheld by the DC Circuit.
 
Deadline for Abstracts: 2012-07-18
 
Registration:

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702355?channel=hummolgen 

E-mail: referral@complianceonline.com
 
   
 
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