About EBSA21 - Course M - Large scale GMP and containment, do disposables fit in?
EBSA21 - Course M - Large scale GMP and containment, do disposables fit in?
Manufacturing protocols have particular focus on good manufacturing practices (GMP) aiming at product safety. Biosafety professionals need to understand the differences and how to communicate with GMP professionals about biosafety and biosafety measures. This course provides insights on where GMP and biosafety meet or diverge, where balance needs to be established.
Biosafety professionals confronted with introduction of disposables, design new lab or production facility
Enigineers working in a BSL 2 or higher environment
Understanding of balancing GMP and biosafety
Are disposables suitable in your situation
- Use of disposables: safe use for product and environment
- Waste streams
- Connection points
- Measures required for maintenance
Citation of the respective sections of CWA 16335:2011 Biosafety professional competence
The topic refers to some sections of competence 7.2.6 and training specifications C.22.214.171.124 Containment principles and specialist training specification C.2.2.8 biosafety and Good Manufacturing Practices (GMP)