Conference Details

FDA 21 CFR Part 11 Compliance - Validation Seminar 2018

Date :

Place : Germany, Germany

Website :

Contact Person:John Robinson

Description:

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

FDA 21 CFR Part 11 Compliance - Validation Seminar 2018 will be held in Germany,Germany on date 2018-05-04

Deadline for abstracts/proposals : 1st May 2018

Organized By :John Robinson

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. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service.

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 :Germany

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FDA 21 CFR Part 11 Compliance - Validation Seminar 2018

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