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Computer System 2021 - "FDA Computer System Validation3 Days Virtual Seminar"
Topics/Call fo Papers
Boot camp is tough and challenging. It is a three-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios.
We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company.
Understanding of how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
The purpose of each validation deliverable and hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report
Speaker:
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries,
We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company.
Understanding of how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
The purpose of each validation deliverable and hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report
Speaker:
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries,
Other CFPs
- Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines Training
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- Privacy Issues in the Workplace
- Workplace Violence and Active Threat Response: Preparation and Readiness Topics
Last modified: 2020-12-30 23:35:11