Training & consultancy

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.

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.

Amer Alghabban, a clinical pharmacologist by training, is a senior executive with over 30 years’ experience within pre-& clinical R&D, pharmacovigilance and GxP (GLP, GCP, GCLP, GMP & GVP) QA. Invited speaker at over 130 conferences, the author of The Pharmaceutical Medicine Dictionary, The Dictionary of Pharmacovigilance, and others. Previous positions; VP QA Compliance & Training at Karyopharm, Global Head QA at Merck Serono, Global Head GxP QA at Arpida, Clinical QA Manager at Novartis, and first Pharmacovigilance Compliance Officer of the MHRA, Assistant Editor for 11 medical journals and Course Director-RQA Pharmacovigilance Auditing Course.

Aaron is Cultures Laboratory Supervisor in RSSL's Global R&D Biological Sciences department.

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.

Zoë obtained her PhD from the University of Bath and the Department of Health working on the optimisation of vaccine production. She then spent over 10 years working as a research fellow identifying novel autoantibodies and determining their role as clinical biomarkers. This incorporated the development and validation of multiple diagnostic assays, development of complex diagnostic algorithms and the formation of an accredited diagnostics service. Zoe is currently employed by Accord UK as a Senior Scientist & Chemometrician. Her role covers a range of expertise including preparation of regulatory filings and investigational medicinal product dossiers, review of updates to ICH guidelines and acting as a subject matter expert in statistics and data analysis, where she is experienced in using a range of analytical software programmes and training statistical methods.

Gavin Brooks is a Visiting Professor at both the University of Reading and at Buckinghamshire New University. He has a first-class honours degree in Pharmacy and a PhD in organic chemistry and pharmacology and he was the founding Head of the Reading School of Pharmacy in 2004. He was Pro-Vice Chancellor for Teaching and Learning and Deputy Vice Chancellor at the University of Reading until 2019 and Provost and Deputy Vice Chancellor at Buckinghamshire New University until April 2022. Gavin has held a number of external appointments related to healthcare and skills both nationally and internationally and currently is: an Independent Consultant and Specialist in Higher Education and Skills; Vice Chair of Governors at Newbury College/University Centre Newbury; and Principal External Examiner at Royal Holloway University of London.

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.

Bruce Davis carries out training and consultancy in a number of science and risk-based topic areassuch as Quality Risk Management (QRM); Quality by Design (QbD); Process validation/ qualification; Technology transfer. He is an experienced trainer with many years’ experience of the pharmaceutical industry. He tries to ensure participants have an engaging and learning training experience. He has always been interested in the importance of having a patient and science and risk-based approach and in its application during training. He runs his own consultancy business and has done for the past 11 years. He formerly worked at AstraZeneca, where he had an international engineering role, being responsible for putting in place new manufacturing and development facilities. He is past chair of ISPE and has contributed to or colead a number of their industry guides, including Technology Transfer, Process Validation, and a chapter on ATMPs.

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

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.

Caroline has over 20 years’ experience in the pharmaceutical industry across several companies. In 2013 Caroline moved to QA, taking a role as a QA officer for 3rd party compliance to pursue the journey of QP training. Caroline qualified as a QP in 2015 and since that time has performed Qualified Person duties across both QA operations and Supplier Quality areas in several leadership roles. Currently Caroline is Head of Quality, UK Third Party, QP at Accord-UK Ltd. She and her team provide quality oversight and management of all companies manufacturing, packing, testing liquids, tablets, creams, capsules, ointments, suppositories, medical devices, and some sterile products on behalf of Accord-UK Ltd under their MIA.

Leo is a pharmaceutical professional with over 20 years of experience across the industry and is currently RSSL’s Training & Development Specialist. He is an experienced L&D professional with a broad depth of knowledge as a trainer, coach, and mentor. He has helped many people on their way to successful career paths.

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.

Elena is a Lecturer in Pharmaceutical Chemistry (Teaching and Research) at the University of Reading, specialising in Pharmaceutical Chemistry and Pharmaceutics. Elena graduated with a first class honours degree in Chemistry and then a PhD in Pharmacy.

Sue has run her own consultancy since 2009 and works with companies all around the world. She became a QP in the mid 1980’s and a QP Assessor in the early 2000’s. Although her core knowledge and experience is in GMP, she has built up knowledge and experience in Good Distribution Practice (GDP) and has helped write a guidance document published by PQG and ECA which expands upon the EU GDP Guideline. Sue has dealt with many GMP systems in her over 40 years’ experience in the industry; including WHO whilst involved in a development project in a number of African countries, funded by UNIDO. Sue has been a QP for many years and understands the complexity of the role and its position within a company. She is an inspiring trainer being able to break down complex topics into understandable sections and can “train” at all levels in an organisation. She understands what it is that is important in fulfilling the role of a QP.

Andy has over 35 years of pharmaceutical industry experience, beginning at Smith and Nephew in 1985 as a microbiologist, progressing to QA Microbiology Manager in 1996. During that time, he gained experience in QA and QC activities of the manufacture of sterile eye drops (terminally sterilized and aseptically filled), aseptically filled sterile creams and non-sterile syrups. In 2003 he became the RSSL Pharmaceutical Training Manager with responsibility for providing commercial pharmaceutical training courses. In 2007, Andy moved to Catalent pharma Solutions, in Swindon, as Microbiology Manager leading a team responsible for microbiological control of freeze-dried tablets and soft gel capsules. Andy gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events. In 2012 Andy set up ABM Consulting Ltd which offers services specializing in Microbiology, QA and Good Manufacturing Practice. Andy is also treasurer for the UKs foremost microbiology organisation, Pharmig.

Jay is currently a lecturer in Biomedical Sciences, Programme Director and Admissions Tutor for BSc Microbiology at the University of Reading. In addition to teaching I also lead a research group investigating a variety of exciting Microbiology projects including developing a new vaccine for Polio and researching mechanisms of action of metal-ion based antimicrobials. I completed my PhD in Molecular Microbiology at the University of Reading in 2009.

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.

Now an independent consultant, Tony had 32 years experience in the regulation of pharmaceuticals with MHRA, with 22 years within the MHRA Inspectorate leading on the most high profile and complex inspections. Tony has been involved in the development of most UK GDP policies and has a deep understanding on the practical application of GDP and the Human Medicines Regulations and the medicines supply chain.

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.

Rebecca is a Qualified Person and Responsible Person (Eligible to act as a Qualified Person under the permanent provisions) with expertise with Biotechnology products and provision of support for Advanced Therapy Medicinal Products (ATMP). She has held Director positions at some of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

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.

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).

Adam is an experienced Pharmaceutical/Biopharmaceutical QA professional, with over 35 years GMP, GDP, ISO 9001, Pharmaceutical Quality Systems, and audit experience. Adam is a Microbiology and Chemistry Graduate and started his career in QC laboratories within the NHS, before moving into private industry. He then moved into QC and QA roles within different contract manufacturing companies. In 2004 he joined Wyeth (now Pfizer). He also completed his EU Qualified Person training during this time and within Wyeth led a team responsible for contract manufacturing operations in Europe, Middle East, and Africa. He has held positions in QC, QA, Regulatory, R&D, Operations, Technical Support and Validation. He has a wide experience of dosage forms and specialises in Sterile Manufacturing and US FDA PAI readiness and remediation. Adam established his own consultancy in July 2010. He is an active, highly experienced international auditor and has worked extensively in India, China, Pakistan, Middle East, Japan, and the USA. Adam has worked with a wide range of personnel and across many countries. He has also held senior leadership and board roles and throughout his career he has promoted a positive ‘Quality Culture’. He is passionate about passing on his personal experience to others, through education, coaching, mentoring, and training.

Charlotte has many years experience as a RP / QA / Lead Auditor professional with international experience encompassing all aspects of the auditing process, including: inspection, assessment and assurance of GMP / GDP guidelines, managing internal audits and compliance reviews.

John Spenn is an experienced quality professional with over 25 years in the biopharmaceutical / life sciences industry. John has held senior strategic management and leadership roles and has extensive knowledge and experience in quality management and regulatory processes as well as CQV lifecycle for equipment, facilities, utilities, computer systems, sterilisation and cleaning validation. John is currently a director at Dorset Quality Services offering validation and quality consultancy services to the pharmaceutical and life sciences industry. His previous positions include Associate Director and Head of Validation at Lonza Biologics, Cleaning and Process Validation Manager at Porton Biopharma and Validation Manager at Public Health England.

After graduating Roger worked for Wolfson Applied Technology Laboratories in the development of Micro Total Analysis Systems, Near-Patient Tests and Rapid Assay Devices. Then he joined the R&D Group at Wrafton Laboratories and was involved in formulation and method development for a wide range of pharmaceutical products, and providing contract analytical support for customers. For many years, Roger headed the Stability and Analytical Support teams at Perrigo UK, the country’s largest provider of OTC generic pharmaceuticals, being actively involved in analytical method development, validation and day-to-day application. At his current employer, Accord-UK Ltd, he worked in Pharmaceutical Services managing Product Transfer projects between international sites, before transitioning to Quality Assurance with responsibility for Third Party Compliance issues, and is currently a trainee QP himself.

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.

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.

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.

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.

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.