DESCRIPTION Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry[1][2]. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequently, the number of 483s / Warning Letters due to CSV continue

Date : 23rd November 2017 to 24th November 2017

Place : Australia, Sydney

Website :https://www.eventbrite.com/e/computer-system-validation-and-21-cfr-part-11-compliance-com-a-tickets-38830608395?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry[1][2]. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequently, the number of 483s / Warning Letters due to CSV continue

DESCRIPTION Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry[1][2]. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequently, the number of 483s / Warning Letters due to CSV continue will be held in Sydney,Australia on date 2017-11-24

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Deadline for abstracts/proposals : 22nd November 2017

Keynote Speakers : Angela Bazigos Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as wel

Conference Highlights :Learning Objectives: This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life Sciences Industry and how to implement CSV to ensure successful inspections. It will address the following topics: -What is 21 CFR 11 and Computer Systems Validation -The FDA’s perspective (also, other regulatory agencies) -How to implement 21 CFR 11 and Computer Systems Validation -Special Topics: Excel, Cloud and Busines

Venue :Sydney, NSW, 2000, Australia

Check the event website for more details.