Andrew D. Hopkins, PGDip Lachman Consultants

Andy has a degree in Microbiology/genetics and has worked in the industry for over 40 years. He is currently a Senior Director with Lachman Consultants in the compliance group. This role is a wide-ranging role, including Inspection observation response and remediation, new facility design and upgrades, advice on compliance with FDA, EU and PIC/S good practices, training and mentoring. Andy previously worked for AbbVie 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. Andy worked for 14 years in the UK MHRA as an Expert Inspector. His roles involved working on joint inspections with other regulators including EU National Competent authorities, USFDA and TGA. The role included working with companies with unsatisfactory inspection outcomes including license removal and product recalls. In this role Andy worked on several GMP guidelines including EU GMP Vol. VI part IV for ATMPS and on the PIC/S subcommittee for harmonization. Probably best known for chairing the Working Group for the re-write of EU and PIC/S Annex 1. In previous roles he worked in QC, Validation, QA and Production in a range of sterile and non-sterile products.