The American regulation 21 CFR Part 11: Electronic Records; Electronic Signatures has been one of the most significantly difficult regulations for healthcare manufacturers to understand and implement since its conception and authorisation in 1997. The Interpreting the Regulation 21 CFR Part 11 and revised EU Annex 11 (1 Day) Training Course, seeks to demystify misconceptions and beliefs on what it means for companies.
The course also provides a review and comparison of Part 11 with Annex 11 and related EU GMP Volume 4 Chapter 4 on Documentation.
Regulated life science companies rely on the integrity of their data to ensure product quality. With increasing use of computerised systems in GMP operations regulatory authorities need to be assured that companies can manage the challenges that face them in understanding the complexities surrounding this subject and be confident that implemented strategies are effective.
So if you want to understand 21 CFR Part 11, what has been revised in the EU GMP Annex 11 and Chapter 4, and examine the GAMP®’s interpretation of the guidance, and the subject of data integrity then why not attend our course? |