Andrew D. Hopkins, PGDip Lachman Consultants

Andy has a degree in Microbiology with genetics and has worked in the pharmaceutical industry for over 40 years. His most recent role is working for Lachman Consultants as a Senior Director in the compliance group. This role is a wide-ranging roll, including Inspection observation response and remediation, new facility design and upgrades, advice on compliance with FDA, EU and PIC/S good practices and training and mentoring.

Andy previously worked for AbbVie in the audit and compliance group with a special focus on Microbial Contamination Control in sterile and low Bio burden products and the implementation of EU and PIC/S GMP Annex 1.

Prior to this Andy worked for 14 years in the UK MHRA with his final role being as an Expert Inspector. His roles involved working on joint inspections with other regulators such as EU National Competent authorities, USFDA and TGA. The role also included working with companies with unsatisfactory inspection outcomes including license removal and decisions on product recalls. Whilst in this role Andy worked on several GMP guidelines including EU GMP Vol. VI part IV for ATMPS, on the PIC/S subcommittee for harmonization and with the European Good practice guides for Blood transfusions and components. Andy is best known for his work in commencing and chairing the Working Group for the re-write of EU and PIC/S GMP Annex 1.

In previous roles he worked in QC, Validation, QA and Production in a wide range of sterile and non-sterile products.