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Computer System 2021 - FDA Computer System Validation (CSV)
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.
Other CFPs
- Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact
- Fundamentals of EU MDR and IVDR – Level 1
- Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines
- Designing and Sustaining New and Existing Product Stability Testing Program
- Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Last modified: 2021-05-17 14:34:43