17/18 May 2021
On behalf of PIC/S*, the U.S. Food and Drug Administration FDA is organising a PIC/S Committee Meeting and Seminar for inspectors from Medicines Regulatory Authorities from around the world. This event will have a special focus on the "Management of Risk through the Product Life-Cycle". This also indicates that inspectors focus more and more on integrated Quality Risk Management (QRM) Systems in their inspections and assessments.
According to PIC/S, "Risk management is critical to ensuring product quality, safety, and efficacy". So one important goal of the seminar is to "share tools and techniques generated from experienced inspectors and assessors to enhance inspections".
At ECA's Quality Risk Management Summit, Dr Karmin Saadat, GMP Inspector at the Austrian Agency for Health and Food Safety (AGES) and Chairman of the PIC/S expert circle on Quality Risk Management will give some insight views on how inspectorates will assess QRM implementation in industry.
*PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors.