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Risk-Based Approach 2020 - Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
Topics/Call fo Papers
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.
Learn how to identify “GxP” Systems
Discuss the Computer System Validation (CSV) approach based on FDA requirements
Speaker:
FDA Compliance Consultant for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.
Learn how to identify “GxP” Systems
Discuss the Computer System Validation (CSV) approach based on FDA requirements
Speaker:
FDA Compliance Consultant for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles
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Last modified: 2020-11-05 18:53:29