Public Meeting on Electronic Records; Electronic Signatures (Part 11), 11 June 2004, Washington D.C.

GMP News No. 413

GMP News
22 April 2004
 

Public Meeting on Electronic Records; Electronic Signatures (Part 11), 11 June 2004, Washington D.C.

 
In the publication of the "Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application" in September 2003, the FDA explained its current interpretation of 21 CFR Part 11.

On 11 June 2004, the FDA will hold a public meeting in Washington D.C., on which it "would like public input to assist with their re-examination of part 11." In this context, the FDA intends to discuss the following points: the scope of part 11, risk-based approaches, validation, audit trails, record retention, record copying, and legacy systems.

On the 3 sub-chapters "General Provisions," "Electronic Records," and "Electronic Signatures," the FDA has already published several points for discussion in advance (Meeting Information).
  

Therefore, experienced specialists will discuss topical questions on the new interpretation of 21 CFR Part 11 and show solution approaches in advance of the meeting at the ECA event "Records, Risks and Regulations" to be held in Berlin, Germany, on 12 and 13 May. 

 
Author:
Dr Andreas Mangel
CONCEPT HEIDELBERG

 

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