About EBSA20 - Course K - GMP tools and tips on "Large scale" manufacturing and GMP - what do the biosafety professionals need to know about GMP; tools and tips for the biosafety professional to teach the GMP people about biosafety

Instructors: Michel Cereghetti and Anneke Griffioen

Short description of the course:

This one day course will give understanding of different aspects of GMP and Biosafety. An interactive workshop combining theory and practical examples covering GMP practices and biosafety operational procedures. Target audience includes:  laboratory managers, manufacturing managers, QA managers and biosafety officers in charge of GMP laboratories and production facilities dealing with contained microorganism.

Objectives:

The participant should be able to explain how a GMP facility is designed and operated, could identify areas of conflict with biosafety principles and could suggest solutions

Main Topics:

• What do the biosafety professionals need to know about GMP;
• Tools and tips for the biosafety professional to teach the GMP people about biosafety;
• How to deal with contradictions between GMP and biosafety requirements
   

CWA 16335:2011 Biosafety professional competence reference

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): fundamental principles of GMP; GMP management systems; GMP facility requirements; conflict and solutions between GMP and biosafety.