Training & consultancy

Alex Hall started out in analytical laboratories in the pharmaceutical industry in 1990, before moving into quality assurance, working with major pharma companies. A QP herself since 2000, Alex is a passionate supporter of QP training and development, both as a member of the Pharmaceutical Quality Group (PQG) committee and during her nine years as an Assessor for the Royal Society of Chemistry (RSC).

Andy Beal is an experienced life science professional with over 20 years’ experience in the pharmaceutical / biopharmaceutical industries (FDA and MHRA regulated). Andy is a subject matter expert in Cleaning Validation and Process Validation and is currently a validation consultant working with pharmaceutical clients in both the public and private sectors.

A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.

Arvind delivers training programs on the topics related to QP study guide modules and problem-solving scenarios, OOS Investigation, Statistical process control and sampling, QRM tools and Root Cause Analysis techniques, Legislation Impact assessments and quality evaluation/Gap analysis.

Bruce Davis has worked in the pharmaceutical industry for over 25 years, including roles within AstraZeneca spanning International Engineering of Facilities, facilitation of Quality by Design, capital and asset programmes and strategy. He has been responsible for training regulators and is a past Chairman of ISPE.

With extensive knowledge of business operations and processes, manufacturing operations, logistics, printed packaging and pharmaceutical industry applications, David Abraham has worked in and alongside working parties at national and international level, developing guidance and standards for the industry. He has been instrumental in the development of the PS 9000 publications.

With over 30 years industry experience, Donna Connew has worked in stability and method development laboratories, process technology, GMP auditing, incoming materials QC, supplier quality, production QA and clinical trial QA. A QP since 2001, Donna has worked in the generic pharmaceutical industry and also as a contract auditor of API facilities.

Gabor originally qualified as a pharmacist and then transitioned into industry. He has experience of working in sterile manufacturing as production manager and then various Quality Assurance roles with responsibility for GMP and GDP compliance. In 2016 Gabor then became a Qualified Person, with responsibility for IMP and sterile products. He now works with Paul Palmer delivering GMP and GDP related consultancy and training services.

Professor Gavin Brooks is Pro-Vice Chancellor (Teaching and Learning) and Professor of Cardiovascular Research at the University of Reading. Elected a Fellow of the American Heart Association in 2001, he became founding Head of the Reading School of Pharmacy in 2004. He has served as Chairman of the International Pharmaceutical Federation (FIP) Special Interest Group on Pharmaceutical Biotechnology and, until recently, was Chairman of the South East Universities Consortium for Biopharma Skills.

Graham is a permanent provisions eligible Qualified Person (QP) who has gained extensive QC and QA experience within the Pharmaceutical Industry since 1983. Recent positions have focused upon the application of GMP and design/implementation of Quality Systems at international manufacturing Sites and R&D facilities - with extensive experience gained on all commercial dosage forms plus Active Pharmaceutical Ingredients (API) and Investigational Medicinal Products (IMP).

Jacqui has over 17 years’ experience in the pharmaceutical industry, across diverse therapeutic areas and portfolios, Jacqueline has a broad knowledge and understanding of the legislative and regulatory requirements governing the pharmaceutical industry, with a specific focus on Pharmacovigilance/Drug Safety and the EU/UK regulatory framework. Jacqueline has significant experience in the implementation of fully compliant procedures across all aspects of Pharmacovigilance.

Jamie currently heads the sterility testing team within the pharmaceutical microbiology department at RSSL, he oversees validation, method development and the routine analysis. Jamie has experience in sterile and non-sterile manufacturing environments and is a microbiology consultant to both the sterile and non-sterile pharmaceutical sectors.

Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.

Jenni has 27 years’ experience in the Pharmaceutical industry, 8 in Quality Control and the remainder in Quality Assurance whilst working as a senior quality professional in a high volume fast paced global Generic environment. Currently acting as a Qualified Person and a Responsible Person, she has extensive experience in GMP and GDP. Jenni is currently working as the of Director Supplier Quality, Qualified Person/Responsible Person for Accord-UK Ltd (formerly Actavis UK Ltd) based in Barnstaple, N. Devon. She is responsible for UK and EU Quality teams with oversight of Contract Manufacturers/Suppliers/Service providers, the Corporate Audit team, Good Distribution Practice (GDP) policy across Europe, Middle East and North Africa, and Artwork quality related processes.

Lainy Russell is a highly experienced senior leader who works as an incredibly successful trainer, coach and mentor. In her training and coaching she has helped many people, with some of the most challenging situations that managers and leaders face today.

Lindsay’s career in the life science arena spans over 15 years, with firsthand experience in preclinical research, clinical trial design and product development within the field of cell therapy and regenerative medicine. Lindsay has experience within both the academic and industrial sectors, working as Chief Scientific Officer of a cell therapy company and Associate Professor in Stromal Cell Biology at The Karolinska Institute in Sweden. She has been presented with multiple awards for her research and is the named inventor on numerous granted patents for her research. She has extensively published in the field of regenerative medicine and the use of advanced therapies (ATMPs) for immune mediated disorders including Graft versus Host Disease, and Type I Diabetes.

Lisa Banwell is an experienced, technically qualified Quality and Regulatory consultant, working in regulated industries, including Medical Device manufacturing, Pharmaceutical Analysis and Fine Chemical manufacturing. She has specific experience in auditing, inspection management, Competent Authority communication and regulatory strategy and registration; her expertise spans infusion products, contact lens products, single use sterile medical devices, neurophysiological and vascular diagnostic/monitoring equipment.

Neil is a Microbiologist with over 30 years experience in the pharmaceutical industry. Neil Treasurer of the Pharmaceutical Quality Group and actively involved in running the annual MHRA/PQG meeting. In 2012 he moved back to a role as QA Group manager, QP and RP on the license at AstraZeneca’s second largest manufacturing site at Macclesfield in Cheshire with primary responsible for the site QMS, internal and external inspections, licensing, issue management and recall. In 2018 he moved to AstraZeneca Corporate Quality as Global Quality Director primarily responsible as Global Business Process Owner for Complaints.

Paul has over 30 years in the pharmaceutical industry and has been a Qualified Person and Responsible Person since 2006. He has an impressive resume, having worked for some of the largest pharmaceutical companies holding Head/Director of Quality, QP and RP roles on a permanent and contract basis. Since 2011, Paul has run is own pharmaceutical consultancy business providing; QP, RP, auditing, inspection preparation, regulatory compliance, QP mentoring and also GMP and GDP training services. These services have been delivered to pharmaceutical companies who's functions cover, clinical research, small and large molecule medicines manufacture and all aspects of the pharmaceutical supply chain.

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

Roger Steward currently heads the stability group for Perrigo UK, and is actively involved in analytical method development, validation and day-to-day application. He has extensive experience in formulation and method development for a wide range of products and has provided contract analytical support for a wide range of pharmaceutical customers.

Sion is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11 and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He received the FDA Group Recognition Award for work on Part 11.

Sue has worked in the industry for over 38 years, principally in quality and technical roles. She has a wealth of experience having held European Director & VP level positions at companies such as Eisai and Shire. For the last 11 years, Sue has been an independent consultant providing services across all major dosage forms and more recently ATMPs.

Suzanne is a biotechnology professional with over 30 years’ experience in academia and in the biotechnology industry. She spent 20 years at Lonza Biologics in Slough, during this time, she held several positions including purification process development, scale up and technology transfer to GMP manufacturing facilities within the Lonza network. Suzanne is Director of Cell and Gene Therapy Technology at Orchard Therapeutics, a CGT company which focuses on treatments for rare genetic diseases.

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. Tim is a member of several editorials boards and he has written 30 books and over seven-hundred book chapters, peer reviewed papers and technical articles relating to microbiology and pharmaceutical and healthcare sciences.