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VIDEO: Quality Risk Management and Annex 1

The Principal Advisor at Particle Measuring Systems shares current information regarding Annex 1 Revision 12 Draft regarding Quality Risk Management. The use of QRM principles and risk-based approaches are prominent expectations throughout the draft Annex 1 Revision. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing.