GAMP5 and 21CFR PART 11 Compliance with Computer System Validation

GAMP5 and 21CFR PART 11 Compliance with Computer System Validation


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About The Event


I take this opportunity to invite you for GAMP5 & 21CFR PART 11 Compliance with Computer System Validation which is going to be held in Mumbai on 22nd and 23rd of February.

Using the GAMP Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and Signatures as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to the-minute information on the status of FDA's current re-examination of the regulation, including a discussion of the Agency's latest Part 11-related guidance and inspection assignments. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues.

Key Features:

1) Why the need for Validation came in to picture. History Of Validation
2) Benefits of Validation
3) How we can get Good System
4) How validation helps to improve your business
5) Computer Validation as per GAMP5
6) Why Validation? Deliverables of the Validation?
………………………………………………….. And many more...

Could you please let me know your interest for being a part of the training program?

Please don’t hesitate to contact if you have any questions.

Thanks & regards

For Marketing and Media Partnership
Hemangi Pagare
Marketing Manager
+91 84249 09009