Andrew D. Hopkins, PGDip AbbVie Inc.

Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companiese) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chair for the working group for the revision of Annex 1 • Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.