2024 PDA/FDA Joint Regulatory Conference

Andrew D. Hopkins, PGDip AbbVie Inc.

Andrew D. Hopkins, PGDip

Andrew D. Hopkins, PGDip AbbVie Inc. Director, Operation Quality QA Audit and Compliance

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 40 years Currently Andrew is a Director of Compliance at Abbvie with responsiblity for Microbiological contamination the role includes developing long term financial strategy for site investment, assessment of manufacturing sites andTraining and mentoring. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in several areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companies) • 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 Chaired the working group for the revision of Annex 1 • Supporting industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Before joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.