Description
The Advanced Computerized Systems Validation (CSV) Workshop provides a deep and practical understanding of how to validate computerized systems used in GMP-regulated environments. Participants will explore the complete lifecycle approach to CSV — from planning and risk assessment to execution, documentation, and maintaining a validated state.
This workshop bridges regulatory expectations such as EU Annex 11, FDA 21 CFR Part 11, and GAMP 5, emphasizing data integrity, system security, and audit readiness. Through real-life examples, templates, and validation case studies, participants will learn to implement effective, compliant, and sustainable validation programs for laboratory, production, and quality systems.
Who Should Attend
This workshop is ideal for professionals responsible for computerized systems and data integrity compliance, including:
- Quality Assurance and Validation Engineers
- IT, Automation, and CSV Specialists
- Quality Control and Laboratory staff
- Regulatory Affairs and Compliance Officers
Key Takeaways
- Flexible Attendance Options – Join in-person at VALOR or virtually through our live interactive platform.
- Recorded Sessions – Enjoy limited access to recordings for one month after course completion for review and reinforcement.
- Repeat for Free – Participants may re-attend inperson any future round of the same course at no additional cost.
- Accredited Certificate – Receive a QR-coded certificate for authenticity verification and professional recognition.
- Comprehensive Resources – Access digital materials, trainer support, and post-course assessments through VALOR’s e-learning platform.
Course Topics
- Data Integrity & Data governance
- DIRA
- Validation Life cycle
- Workshop 1 Spread Sheets
- Workshop 2 BMS Software
- Workshop 3 HPLC Software validaation
Number Of Sessions
6 Sessions