Validation Life-Cycle (from DQ to PQ) approached as per GMP Annex 15
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
- Manufacturing
- Quality Assurance
- Quality Control
- Validation
- Engineering
- Maintenance
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
Regulatory & technical references
- EU-GMP Annex 15 “Qualification and Validation”
- 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
Yes
Final evaluation quiz
Yes