Description
Computer System Validation for Professionals program includes an introduction to the international principles and regulations behind effective validation and qualification. The program offers an introduction to the international principles and regulations behind computer systems validation and compliance with regulation 21 CFR Part 11 on electronic records and electronic signatures. It outlines FDA requirements on electronic records and electronic signatures and describes in detail how to assess software suppliers and their products. It sets out principles of GAMP®5, risk assessment, and risk management. The program moves on to provide an introduction to computer systems validation as required by GxP regulations.
Several individual courses are included in this program which are as follows: 1) Introduction to Validation; 2) Computer System Validation- Part One; 3) Computer System Validation- Part Two; and, 4) Compliance with Regulation FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures).
See individual course pages for more information and outline of the topics discussed.
