Training & consultancy

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.

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.

Caroline is a Quality Assurance Consultant with over 25 years experience in pharmaceuticals. Caroline is a Qualified Person (under Permanent Provisions) for Commercial and Investigational Medicinal Products and named on licences and working as an active QP since 2004. She specialises in solid dose, liquids and steriles including biologics, ATMPs and radiopharmaceuticals. I offer contract / interim QP services to manufacturing authorisation holders in UK, Ireland and the rest of the EU. Caroline has experience working with clients on operation and management of their Quality Management Systems from the design and implementation of a new QMS through to routine operation and maintenance of existing quality systems. She also as knowledge and experience of managing and supervising Quality Assurance departments from managing teams of laboratory technicians to supervising a team of QPs, as well as, a background in Pharmaceutical Microbiology including management of microbiology laboratories for a biopharmaceutical company.

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.

Clive is a chemist by background and a pharmaceutical Qualified Person. Clive has held senior quality positions with Sanofi and Parexel and has expertise is in GMP quality & compliance matters concerning the manufacture of pharmaceutical products. Clive has had both manufacturing site and corporate quality responsibilities. Clive also spent a number of years in pharmaceutical consultancy and during his pharmaceutical career has had direct experience in dealing with major regulatory authorities' inspections, such as US FDA, EU, Japan, China and Russia.

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. He also has held a number of external appointments related to healthcare and skills both nationally and internationally.

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.

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.

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.

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 industry experience in a variety of roles and disciplines. Caroline is currently Head of Quality, UK 3rd Party and a Qualified Person. Caroline started her career in QC and becoming Head of QC Analytical Services at Activis. Caroline then moved into QA initially working on 3rd party compliance and supporting QPs and is now in her current role as Head of Quality and a QP.

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 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.

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.

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.

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.

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).

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.