Course Descriptor
This two-day course provides an introduction to the typical Commissioning, Qualification, and Validation (CQV) concepts and activities employed in a modern biopharmaceutical manufacturing facility. The course will include both hands-on practical and theory components, introducing topics such as CQV, Process Validation Lifecycle, Validation Risk Analysis, FAT/SAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Continuous Process Verification & Automation systems. Equipment such as stainless-steel bioreactors, utilities skids, and mobile vessels, along with Piping & Instrumentation Diagrams (P&IDs) and a tour of NIBRT’s Utilities and Pilot plant will be utilised to provide an understanding of how CQV concepts are applied to biopharmaceutical production facilities
2 Days Onsite in NIBRT
Commissioning Qualification and Validation
€1,900.00
Dates:
- 08/06/2023 - 09/06/2023
5 Places Remaining
- 05/10/2023 - 06/10/2023
8 Places Remaining
Fee:
€1900Suitable for:
This course is designed for operators, technical staff, engineers, managers, and graduates wishing to gain an introductory knowledge of Commissioning, Qualification, and Validation activities in the Biopharmaceutical Industry.
Downloads:
For further informationWho should attend
This course is designed for operators, technical staff, engineers, managers, and graduates wishing to gain an introductory knowledge of Commissioning, Qualification, and Validation activities in the Biopharmaceutical Industry.
Key topics covered
Introduction to Commissioning, Qualification, and Validation (CQV)
NIBRT Utilities and Plant Tour
Process Validation Lifecycle
Validation Risk Analysis
FAT/SAT
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Continuous Process Verification & Automation Systems
Assessment
