DESCRIPTION The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: -Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News -Overview manage and Key Requirements of Part 11 & Annex 11 -How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? -How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11

Date : 23rd November 2017 to 24th November 2017

Place : Australia, Sydney

Website :https://www.eventbrite.com/e/how-tga-fda-other-regulatory-authorities-inspect-computerized-systems-for-data-integrity-com-a-tickets-38831011601?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: -Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News -Overview manage and Key Requirements of Part 11 & Annex 11 -How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? -How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11

DESCRIPTION The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: -Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News -Overview manage and Key Requirements of Part 11 & Annex 11 -How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? -How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 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 w

Conference Highlights :Learning Objectives: This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: What is Data Integrity and how is it implemented? How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance? Data Integrity Frequently Asked Questions Validation Master Plan Risk Based Assessment

Venue :Sydney, NSW, 2000, Australia

Check the event website for more details.