Learn How To Think Like The FDA ®
“Established since 1999”
REGULATORY COMPLIANCE SERVICES
GCGI’s CSV CERTIFICATION PROGRAM™
Is available through online webinars. Training activities are presented live including individual and group discussions, workshop exercises and Q&A sessions.
The Computer System Validation (CSV) Certification Program™ encompasses three (3) Certification Training Modules for a total of
sixty (60) hours or ten (10) training days.
The program addresses the application of Software Development Life Cycle (SDLC) to automated Manufacturing and Laboratory systems.
Each participant will be able to understand the rationale within the CSV process and overall, understand “How FDA Thinks” when auditing firm’s CSV, Data Integrity in computerized systems and Part 11 documentation.
Three CSV Certification Training Modules are available to personnel with diverse educational backgrounds.
The certification program is delivered by Johnny Guerra, a former FDA Computer Specialist, ensuring that participants learn all CSV
requirements for the proper detection, correction and prevention of computer and software anomalies that could impact on product quality and validated processes and systems as well.