About EBSA21 - Course M - Large scale GMP and containment, do disposables fit in?

Back to meeting overview

EBSA21 - Course M - Large scale GMP and containment, do disposables fit in?

Wednesday, April 18, 2018 from 9:00 AM to 5:00 PM (CET) EBSACourse , 2018

Anneke Griffioen and Vibeke Halkjaer-Knudsen
 
Course description

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.

Target audience

Biosafety professionals confronted with introduction of disposables, design new lab or production facility
Enigineers working in a BSL 2 or higher environment

Learning objectives

Understanding of balancing GMP and biosafety
Are disposables suitable in your situation

Main topics

  • 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.2.1.2.4 Containment principles and specialist training specification C.2.2.8 biosafety and Good Manufacturing Practices (GMP)