Good Laboratory Practice Regulations - No Cost Library

Good Laboratory Practice Regulations,(Drugs and the Pharmaceutical Sciences) - 4th Edition

   Author(s): Weinberg Sandy  

        Publisher: Informa Healthcare, Year: 2007   

                                      

  

 Description: 

Recent developments in the interpretation and compliance of 21 CFR Part 11 have changed the focus of Good Laboratory Practice (GLP) regulations to focus on the adoption of electronic signatures, data archiving, electronic record protection, and laboratory process automation. This all-encompassing fourth edition discusses any crucial element of the regulations regulating Good Laboratory Practice (GLP) and explains successful implementation techniques in a number of laboratory settings. This revised and extended classic text provides new information about the application of 21 CFR Part 11 to the laboratory environment, GLP reporting systems, laboratory risk analysis, system validation, and inspection, process analytical technology, and cost management for pitfall prevention and enforcement assurance in various research environments.

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