Share Your Research, Maximize Your Social Impacts
Main Menu
Searching By
PARTNERS
Computer System 2020 - Best Practices To Help You Pass An FDA Computer System Validation Audit Training
Topics/Call fo Papers
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems.
Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
“GxP” – Good Manufacturing, Laboratory and Clinical Practices
Speaker:
Carolyn Troiano is an independent consultant with more than two decades of experience working in pharmaceutical and biotechnology companies in roles
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems.
Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
“GxP” – Good Manufacturing, Laboratory and Clinical Practices
Speaker:
Carolyn Troiano is an independent consultant with more than two decades of experience working in pharmaceutical and biotechnology companies in roles
Other CFPs
- 10 Facts about Detailed Investigations: How to avoid an observation - Webinar
- Live Webinar How to Implement a Compliant Training Program and Reduce Human Error
- FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
- Understanding Quality Control Testing Webinar
- Remote Deposit Capture RDC for 2020 - Rules Regs Risks and Reg CC
Last modified: 2020-11-24 01:44:01