Computer System 2020 - Computer System Validation Professional Certification Program 3 Days

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),
Speaker:
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.