This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.

Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

The course will provide principles and an overview of the overall computer systems compliance. This course includes categorisation of software and hardware as per GAMP 5, the different validation strategies etc. More discussion will be on developing URS, FRS,FAT,SAT,IQ,OQ and PQ. This session will explain you further the test strategies specifically black box strategies so that the validation person can easily do the validation by following the instructions given in this video.

In this learning session, we will clear your validation master plan and validation master report concept. Lastly some common questions by many experts and answer to these questions are available at the last of session.

Training Course will benefit all who use cGXP computerised systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.