XMHRA Consultants, UK
A graduate in Bsc Biomedical Science, Shahbaz worked in Biotechnology for a Contract Manufacturer of Active Pharmaceuticals Products (API’s) as a Production Manager within a GMP Facility for 7 years prior to joining the MHRA as a GDP Inspector. He spent a very enjoyable and rewarding 5 years as a GDP inspector conducting hundreds of inspections of pharmaceutical wholesale distributors and also working alongside enforcement. GDP inspections covered the whole range of wholesale distributors of all sizes and complexity. He has also represented the MHRA at trade shows and been involved in the PICS Exchange Programme working with regulators in the EEA and USA. Most recently he has spent time back in Industry as a Senior GMDP auditor before setting up XMHRA Consultants Ltd.
XMHRA Consultants, UK
Recently retired GDP Inspector, Steve was a Senior GDP Inspector at the MHRA for 16 years having conducted GDP inspections of companies of all sizes and complexity. He was involved in the editing and publishing of the MHRA Rules and Guidance for Pharmaceutical Distributors 2016 & 2017 (Green Guide) and has contributed to various external publications. His Blogs on different areas of GDP can be found on the MHRA website. He was an active member of the PICS GDP Working Group since 2008 and latterly as Chairperson to publish the PICS GDP guidelines.
Distribution & Cold Chain Expert, UK
A graduate in Bsc Chemical Engineering from the University of Kentucky, USA, Saddam has extensive experience in GMP environment with an engineering, quality and distribution background with major pharmaceutical industries in multi-cultural environments. Saddam is a senior quality management executive who has been successfully leading variety of projects in cold chain, GDP standards, supplier management and customer relation. To his major achievements belong: Improving compliance and quality standard for storage and distribution of temperature sensitive products at GSK; Reducing waste and cost avoidance by integration of new cold chain transport solutions in both Pfizer and GSK; Commissioning of new Manufacturing facility (Aseptic Services Unit) for Fresenius-Kabi and bringing it in compliance for Specials License from MHRA; Distribution Cut-over and Supply Chain Quality Integration of GSK-Pfizer product divestment and GSK-Novartis Vaccines deal.