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Computer System 2021 - "FDA Computer System Validation 3 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.
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.
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.
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.
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.
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- COVID19 Legislative update
Last modified: 2021-04-15 14:33:09