Conference Details

Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance

Date :

Place : Switzerland, Zurich

Website :

Contact Person:John Robinson

Description:

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. 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. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools

Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance will be held in Zurich,Switzerland on date 2018-05-08

Deadline for abstracts/proposals : 5th May 2018

Organized By :NetZealous LLC DBA GlobalCompliancePanel

Keynote Speakers : Angela Bazigos CEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds

Conference Highlights :Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. 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 d

Venue :Zürich, Switzerland

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Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance

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