Validation principles methodology and documentation
Module Lenght
from 1 day and a half to 2 days
Agenda
- Regulatory aspect from International Agencies
- Technical Background
- Validation Life Cycle
- Design Qualification
- Installation Qualification
- Operational Qualification
- Calibration
- Performance Qualification
Target audience
- Engineering
- Validation
- Maintenance
- Manufacturing
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
Regulatory & technical references
- EU-GMP Annex 15 “Qualification and Validation”
- WHO TRS 937, Annex 4 “Supplementary guidelines on Good Manufacturing Practices: Validation”
- PIC/S PI 006-3 “Validation Master Plan – Installation and Operational Qualification – Non-Sterile Process Validation – Cleaning Validation”
- PIC/S PI 007-6 “Recommendation On The Validation Of Aseptic Processes”
- ISPE Good Practice Guide “Applied Risk Management for Commissioning & Qualification”
- ASTM E2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”
Number of trainers
One
Tailoring option available
No
Final evaluation quiz
Yes