Computer System 2021 - Computer System Validation Boot Camp

A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection– ready validation projects.
Manage or participate on computer system projects requiring validation
Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
Understand the process of computer system validation
FDA Regulations and Guidance
Other Regulations and Guidance (EMA, ICH, EU, MHRA, PIC/S)
Exercise: Exploring the Regulations using the fda.gov website
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.