It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also worked in the manufacturing sector and is a Chartered Chemist and Chartered Quality Professional.
In his role as an Inspector, Stephen conducts GCP and GLP inspections of commercial organisations and laboratories in the UK in addition to inspection of overseas facilities as part of the MHRA inspection programme for organisations conducting Bioequivalence studies.
On 22nd September 2016 the MHRA Inspectorate will be holding another GLP and GCP Laboratories Symposium.
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About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.