Adam is a Pharmaceutical/Biopharmaceutical Quality Assurance professional, with over 35 years’ experience across GMP, GDP, ISO 9001, Pharmaceutical Quality Systems and auditing.
Passionate about passing on his personal experience onto others, Adam is involved in the education, coaching, mentoring and training of fellow professionals at any stage of their pharmaceutical career journey.
Alex Hall began her career in 1990, working in analytical laboratories before moving into quality assurance, with several major leading pharmaceutical companies.
A Qualified Person since 2000, Alex is a passionate supporter of QP training and development, both as a member of the Pharmaceutical Quality Group committee and through her nine-year tenure as an Assessor for the Royal Society of Chemistry.
Amer, a clinical pharmacologist by training, is a senior executive with over 30 years’ experience within pre and clinical R&D, pharmacovigilance and GxP QA.
A highly sought after speaker, Amer has presented at over 130 conferences and is the author of The Pharmaceutical Medicine Dictionary, The Dictionary of Pharmacovigilance, as well as several other publications.
Andy Beal is a skilled life science professional with over 20 years’ experience in the pharmaceutical / biopharmaceutical industries (FDA and MHRA regulated).
A subject matter expert in cleaning and process validation, Andy and is currently a Validation Consultant working with pharmaceutical clients in both the public and private sectors.
With over 35 years of pharmaceutical industry experience, Andy began his working life as a Microbiologist in 1985, later progressing to QA Microbiology Manager. During his long career, Andy has gained experience in across a wide range of QA and QC activities.
In 2003, Andy become RSSL’s Pharmaceutical Training Manager with responsibility for providing insightful commercial training courses for those looking to enhance their knowledge and prospects.
Arvind, a Consultant QP, GMP Trainer and Industrial Pharmacist, has over 20 years’ industry experience and specialises in delivering expert training on the topics related to the QP Study Guide.
With hands-on manufacturing and quality assurance experience, Arvind has worked across numerous product types and delivery formats including tablets, capsules, inhalers, ointments, nasal sprays and biosimilars.
Barbara is widely recognised as an expert in the field of allergen management.
Her extensive analytical background, coupled with more than 20 years' experience working with food manufacturers and retailers, allows her to provide support to food businesses in all aspects of allergen management, from risk assessment to implementation of the controls required to manage those risks.
An experienced tutor, Bruce understands the importance of engaged, active learning. Focusing on patient safety, Bruce ensures his sessions have a solid scientific approach, providing practical insights and real-world application.
Having run his own consultancy for 15 years, Bruce specialises in risk-based topic areas including Quality Risk Management, Quality by Design, process validation / qualification and technology transfer.
With more than 20 years industry experience, Caroline is dedicated to ensuring pharmaceutical excellence. Becoming a QP in 2015, Caroline has carried out related duties across both Quality Assurance and Supplier Quality for an array of leading organisations.
Currently Head of Quality at Accord-UK Ltd, Caroline provides oversight and management of manufacturing, packing, testing liquids, tablets, creams, capsules, ointments, medical devices and more.
Caroline has a background in Pharmaceutical Microbiology and Quality Assurance, holding a degree in Biomedical Technology and MSc in Industrial Pharmaceutical Studies.
Gaining QP status in 2004, Caroline leads our monthly QP Hot Topics Webtorial sessions and QP Viva Preparation Training days. An ex-QP QP Assessor, Caroline has successfully sponsored and mentored many trainee QPs on their journey to become a Qualified Person.
An experienced international auditor, RP, RPi and QA professional, Charlotte’s skill set encompasses all aspects of the QMS.
Her vast knowledge covers inspection, assessment and assurance of GDP guidelines, the management of internal as well as external audits and more, making her a valuable addition to our wonderful roster of tutors.
An experienced chemist and Qualified Person (QP), Clive has a strong background in GMP quality and compliance.
Clive’s expertise includes managing GMP standards in pharmaceutical manufacturing and ensuring regulatory compliance across diverse markets. He has also worked as a consultant, gaining direct experience with major regulatory inspections by authorities such as the US FDA, EU, Japan, China, and Russia.
With extensive knowledge of business operations and processes, manufacturing operations, logistics and pharmaceutical industry applications, David has operated in and alongside working parties at national and international level.
Developing guidance and standards for the industry, David is held in high regard within the industry and has been instrumental in the development of the PS 9000 publications.
With over 30 years of industry experience, Donna Connew is a seasoned QP who has held roles across various quality and development functions. Her expertise spans stability and method development, process technology, GMP auditing, incoming materials QC, supplier quality, production QA and clinical trial QA.
Since becoming a QP in 2001, Donna has worked extensively in the generic pharmaceutical industry and as a contract auditor for API facilities.
Elana is a lecturer in Pharmaceutical Chemistry (Teaching and Research) at the University of Reading, specialising in dosage forms and the characterisation of pharmaceutical materials.
Elana holds a first-class honours degree in Chemistry and went on to complete a PhD in Pharmacy. Her primary research interests lie in X-ray diffraction techniques and the characterisation of materials.
Gabor began his career as a pharmacist before transitioning to industry, where he gained extensive experience in sterile manufacturing as a production manager.
He later moved into Quality Assurance roles, focusing on GMP and GDP compliance. In 2016, he qualified as a Qualified Person, specialising in Investigational Medicinal Products and sterile products.
A Visiting Professor at the University of Reading and Buckinghamshire New University, Gavin has held numerous national and international healthcare appointments during his long career.
The founder of the Reading School of Pharmacy (2004), Gavin is currently an Independent Consultant specialising in higher education. He is also Vice Chair of Governors at Newbury College/University Centre Newbury and Principal External Examiner at Royal Holloway, University of London.
Graham is a permanent provisions Qualified Person with extensive experience in Quality Control and Quality Assurance. His recent roles have centred on applying Good Manufacturing Practice and designing and implementing Quality Systems across international manufacturing sites and R&D facilities.
Graham has a broad expertise covering all commercial dosage forms, Active Pharmaceutical Ingredients and Investigational Medicinal Products.
With more than 17 years' industry experience, Jacqui has in-depth knowledge of the EU/UK legislative and regulatory requirements, with a particular interest in pharmacovigilance/drug safety.
Highly skilled in implementing fully compliant procedures across all aspects of pharmacovigilance, Jacqui is dedicated to ensuring adherence to industry standards.
Jamie formerly headed the sterility testing team within the pharmaceutical microbiology department at RSSL, overseeing 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 of experience in Quality Assurance, including senior Quality Management roles, with expertise across a wide range of dosage forms.
Her experience spans metered dose inhalers, tablets, capsules, liquids, topical preparations and sterile products, reflecting a comprehensive understanding of quality standards across diverse portfolio.
Jay is a Lecturer in Biomedical Sciences at the University of Reading, where she serves as Programme Director and Admissions Tutor for BSc Microbiology. Leading a dynamic research group, her projects include developing a new Polio vaccine and exploring metal-ion-based antimicrobial mechanisms.
Completing her PhD in Molecular Microbiology in 2009, Jay has since made impactful contributions to microbiology through both her teaching and research.
With over 30 years in the pharmaceutical industry, Jenni has extensive expertise in Quality Control and Quality Assurance. She has led improvements in Pharmaceutical Quality Systems for manufacturing and packing operations, helping to ensure supplier quality across the Netherlands, Ireland and the U.S.
Jenni’s efforts have elevated GMP standards, streamlined deviation close outs and enhanced regulatory inspection readiness.
Jessica has over 15 years of experience in the food industry, beginning her career in the laboratory, where she developed expertise in allergen testing methods.
With a strong understanding of diverse manufacturing environments, Jessica now advises food businesses on effective allergen management strategies.
John is a quality expert with over 25 years in the biopharmaceutical and life sciences industries. He has held senior roles in quality management, regulatory processes and validation (CQV) lifecycle for equipment, facilities, utilities, sterilisation and computer systems.
Currently a Director at Dorset Quality Services, John provides validation and quality consulting.
Kevin brings over 36 years of pharmaceutical industry experience, with a strong background in GMP environments.
He has extensive expertise in laboratory operations, auditing and a deep knowledge of quality management systems, validation and risk assessments.
Lainy is a highly experienced senior leader, recognised for her success as a trainer, coach and mentor. By utilising her expertise, Lainy has supported numerous individuals in navigating some of the most challenging situations faced by managers and leaders today.
Her knowledge in leadership development has had a significant impact on the careers of those she mentors.
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.
Leyla Collins has 10 years’ experience of supporting food businesses and is well versed in advising on allergen risk analysis and effective allergen management.
Leyla is skilled in recommending the best testing approaches and advising on how to collect the evidence required to demonstrate that allergens are being managed effectively.
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.
An award-winning researcher and inventor on multiple patents, Lindsay has extensively published on regenerative medicine and advanced therapies for immune disorders like Graft versus Host Disease and Type I Diabetes.
Lisa is a skilled Quality and Regulatory Consultant with a strong background in medical device manufacturing, pharmaceutical analysis and fine chemical manufacturing.
Specialising in auditing, inspection management, regulatory strategy and authority communication across diverse products, Lisa’s experience covers infusion devices, contact lenses, sterile single-use devices and neurophysiological and vascular diagnostic equipment.
Neil has over 30 years of experience in technical and quality assurance management, specialising in custom pharma quality systems, GMP remediation and transformational change.
A trained microbiologist, Neil is an expert in global supply chain management, third-party oversight and Quality Management Systems. Since 2021, Neil has been an independent consultant with RSSL, specialising in GMP training, leadership, inspection management, as well being a mentor for Qualified Persons.
A proven leader in the pharmaceutical industry, Nick has built a distinguished career driving quality, compliance, and business excellence across global operations. With a foundation in QA and extensive experience spanning QC, Production, MS&T (NPI) and Change Projects, he brings a holistic understanding of how organisations can achieve sustainable compliance and performance.
With over 30 years industry experience, Paul has been a Qualified Person and Responsible Person since 2006.
Paul has run his own consultancy since 2011, offering QP/RP services, auditing, inspection preparation, regulatory compliance, QP mentoring and GMP/GDP training to companies across clinical research, small and large molecule manufacturing and the pharmaceutical supply chain.
Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.
Peter is adept at working with a cross-slice of people to drive a positive ‘Quality Culture’, from shopfloor to boardroom and is passionate about passing on his personal experience to others, through education, coaching, mentoring and training.
Rebecca is a highly experienced pharmaceutical professional, eligible to act as a QP under the permanent provisions. She is a recognised subject matter expert in Biotechnology products and ATMPs, with a distinguished career that includes leadership roles at several of the world's most prestigious pharmaceutical companies. Rebecca has a proven track record in establishing and managing greenfield manufacturing facilities, implementing robust processes, optimising supply chains, and delivering critical strategic milestones. Her global expertise includes leading complex remediation activities, ensuring compliance and excellence across diverse regulatory environments.
Rob has more than 40 years' experience in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA.
With experience of the application of QA across control laboratories, API, solids, creams and liquids manufacture and third-party audit and evaluation, Rob’s knowledge makes him a valued member of our pharmaceutical training programme.
Roger has a broad pharmaceutical background, starting at Wolfson Applied Technology Laboratories with Micro Total Analysis Systems and Near-Patient Tests. He then worked at Wrafton Laboratories on formulation and method development.
Later, Roger led the Stability and Analytical Support teams at Perrigo UK, specialising in method development and validation. At Accord-UK Ltd, Roger managed Product Transfer projects and now oversees Third Party Compliance as a trainee Qualified Person.
Sion is a recognised authority in computer system validation, compliance and international regulatory standards.
A key member of the team behind the FDA's Guidance on 21 CFR Part 11 Scope and Application, Sion later received the prestigious FDA Group Recognition Award for the impact he had made.
Sue is an experienced QP with over 40 years in the pharmaceutical industry, specialising in Good Manufacturing Practice. Since founding her consultancy in 2009, she has advised global companies on best practices and operational improvements.
An inspiring trainer, Sue can break down complex topics in understandable elements and can provide appropriate training to all career levels.
Suzanne is a biotechnology expert with over 30 years of experience across academia and industry. She spent two decades at Lonza Biologics, where she held critical roles in purification process development, scale-up and technology transfer to GMP manufacturing facilities.
Currently, Suzanne is the Director of Cell and Gene Therapy Technology at Orchard Therapeutics, a leading company dedicated to developing treatments for rare genetic diseases.
Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing.
A member of several editorials boards, Tim has written 30 books and over 700 book chapters, peer reviewed papers and technical articles relating to microbiology and pharmaceutical and healthcare sciences.
David Moulding, Registration Standards Specialist at the Royal Society of Chemistry (RSC), will be delivering a presentation covering QP Eligibility and the Application Process.
Tracy is a highly experienced industry professional and QP with over 33 years in pharmaceutical manufacturing, distribution and regulation.
Having served as an Expert Inspector with the UK MHRA’s GMP Inspectorate, Tracey has overseen UK and international licensing, inspections and the development of key regulations.
Particularly skilled in sterile manufacturing and aseptic processes, Tracy has contributed to the Annex 1 GMP update and presented at major global regulatory forums.
Now an independent consultant, Tony has 32 years' experience in the regulation of pharmaceuticals with the MHRA, with 22 years within the MHRA Inspectorate leading onto several 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, the medicines supply chain and the Human Medicines Regulations.
Zoë earned her PhD from the University of Bath and the Department of Health, focusing on the optimisation of vaccine production. With over a decade as a research fellow, she identified novel autoantibodies and developed accredited diagnostic assays and algorithms.
Now a Senior Scientist & Chemometrician, Zoë prepares regulatory filings, reviews ICH guideline updates and serves as a subject matter expert in statistics and data analysis.
