The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing and GMP (Good Manufacturing Practices) Training, and For Clinical Trials and GCP (Good Clinical Practices), Introduction To Meet FDA Regulations in the Use of Computers in Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing, With Emphasis on Computer System Validation and Part 11, Covering FDA Regulations of Laboratory Results, SOPs (Standard Operating Procedures), & OOS (Out of Standard) and OOT (Out of Trend) Results

Author Biography

Daniel Farb MD