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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 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?
Date :
Place : United States, sfo, ca
Contact Person:Eevnt Manager
Description:
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 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?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 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? will be held in sfo, ca,United States on date 2017-12-08
Deadline for abstracts/proposals : 5th December 2017
Organized By :NetZealous DBA as GlobalCompliancePanel
Keynote Speakers : Angela Bazigos CEO, Touchstone Technologies Silicon Valley Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech &
Conference Highlights :VP of IT Director of IT Quality Managers Project Managers (for DATA INTEGRITY / IT) Validation Specialists Database Administrators System Administrators Directors / Senior Directors of Discovery Directors / Senior Directors of Development Directors / Senior Directors of Commercialization Document Managers Training Managers Consultants Data Managers Safety Managers
Venue :San Francisco Airport, San Francisco, CA, United States
Check the event website for more details.
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