Overview: Integrated Qualification and Validation: Good Practice Guide from ECA
Ralf Gengenbach
- History of Qualification
- Why a new guideline?
- Main content and structure
- Comparison to other qualification guides
- The team behind
OM Pharma: Harvest Tank Case Study
Rafael de Souza & Aurélie Di Giovanni-Charpy
- Project introduction
- Lifecycle documents (QRA and URS)
- Cooperation supplier – customer
- Pros and Challenges
- Next steps
Case Study Canexis Pharma: Risk-based Lean Facility Qualification for a Cannabis Production Building
Dr Alexander Sterchi & Sebastian Zeller
- Lean, risk-based and integrated facility qualification
- Efficient collaboration between operations, facility design/construction and qualification experts
- Holistic support for facility design, utilization and operations
- Controlled environments for Cannabis extraction and isolation of compounds
- Combination of GMP and GACP requirements in one common building
Integrated Qualification and Validation Guide
All participants of this course can download the new version 2.2 of the guide free of charge.