Preparing for MHRA Pharmacovigilance Inspections
|Event Date/Time: Sep 08, 2010||End Date/Time: Sep 08, 2010|
Completing Summary of Pharmacovigilance Systems (SPS) documents
Making an inspection checklist
Strategies and hints for the Inspection
Responding to Inspection findings
Keith Cormack has worked in pharmacovigilance for ten years and has been involved in numerous regulatory authority inspections. His career began in Merck Generics in 2000 at the Potter's Bar site which was responsible for global generic pharmacovigilance for the group. In the next eight years with the company he was involved in virtually all aspects of pharmacovigilance and was eventually responsible for compliance within the group, including involvement in the pharmacovigilance auditing of affiliates. In 2008, Keith joined Diamond PV Services as Pharmacovigilance Director and is involved in all aspects of pharmacovigilance for a wide variety of companies. He is currently QPPV for several companies and has fronted two MHRA pharmacovigilance inspections for clients.Keith has also conducted several audits for clients in the past two years.