Adrian Williams
Adrian is the Head of Reading School of Pharmacy and Professor of Pharmaceutics. He researches in broad areas of pharmaceutics, from strategies for improving the dissolution of poorly water-soluble drugs to delivering medicaments to and through the skin. He was appointed as a specialist on polymorphism and Raman spectroscopy by the European Pharmacopoeia and has acted as an expert witness for Merseyside police. He sits on the editorial boards of the Journal of Pharmacy and Pharmacology, the Journal of Pharmaceutical Sciences and Advanced Drug Delivery and has published over 70 research articles and given over 40 invited lectures at national and international meetings.
Aidan Madden
Aidan Madden is a consultant, auditor, QP and trainer working in the pharmaceutical and allied sectors since 2003. Prior to 2003 Aidan worked for 17 years in Ireland for multinational pharmaceutical companies in various quality roles.
Since 2003 Aidan has performed over 100 audits in the manufacturing and services sectors auditing against EU GMP Volume 4 Part 1 for drug products, EU GMP Volume 4 Part 2 for drug substances, EU GMP for Investigational Medicinal Products, EU Good Distribution Practices, ISO9001 and ISO17025 as well as Pharmacovigilance audits.
In addition Aidan has delivered training workshops and seminars to about 70 companies. In the area of Consulting and Project Management Aidan has worked with 76 client companies in the manufacturing and services sectors in 21 countries in Europe, Asia, Americas and India.
Aidan is an active QP on a number of Manufacturer’s Authorisations in Ireland. Aidan holds a BSc in Biochemistry and Microbiology, an MSc in Immunochemistry and a Diploma in Pharmaceutical Manufacturing Technology.
Ashley McCraight, BSc, M.Chem.A, C.Chem, FRSC, MCQA
Ashley runs a business offering a consultancy service to the pharmaceutical industry, which includes performing audits on their behalf. He has 30 years operational experience within the pharmaceutical and food industries which was primarily associated with quality control/assurance activities. Specifically, during this period he was responsible for QA at either a plant, national or global level for over 18 years but also held senior management roles within Manufacturing, Purchasing and Distribution. Within Glaxo, UK, Ashley managed a corporate supplier auditor development programme and had primary responsibility for managing frequent successful FDA and MHRA audits. More recently, as Quality Director, he steered the development of a Global Audit Team within the Pliva (now part of Teva) Group.
He is a Qualified Person and is currently the chairman of the Pharmaceutical Quality Group, which has developed the application standards, PS 9000 and PS 9100 for auditing suppliers of Packaging Materials and Excipients which have now been in use for over 19 years. PS 9000 has been incorporated into ISO 15378 (for Primary Packaging) and the IPAC-RS GMP Guide for Suppliers of Inhalation Components. PS 9100 forms the basis of the recently revised joint IPEC/PQG guide on GMP for Suppliers of Excipients.
He has been the regular pharmaceutical tutor on RSSL’s, IRCA Certified, Pharmaceutical Lead Auditor course for eight years and has delivered ‘Introductory’ training on Auditing, in several formats, with several training organisations for over ten years.
Ashley has published articles1,2 on topics related to auditing and contributed the chapter on 'Supplier Auditing' for the RSC publication; 'Good Clinical Laboratory and Manufacturing Practices' : 2007
Note 1 : The Unwritten Rules for Excipient manufacture : PMPS, Spring 2003
Note 2 : Certificates of Test – European requirements : Pharmaceutical Technology Europe, March 2004
Dr Gary Stephens
Gary obtained his PhD in Neurobiology from Imperial College, University of London in 1992, following a BSc Applied Biology (Hons.) from Hatfield Polytechnic (1984-1988). This provided a sound basis for his research interests in Pharmacology and Neuroscience, more specifically in the electrophysiology of ion channels and receptors. He completed two Post-Doctoral positions, being awarded a Wyeth-Ayerst Post-Doctoral Fellowship (1993-1995) and then taking up a PDRA with Professor Annette Dolphin at University College London (1995-1999). Gary has been a fully independent researcher since 1999. He was sole PI on a Wellcome Trust project grant which supported him as a Wellcome Trust Fellow in the prestigious Biophysics Dept, Imperial College. He then took up a 3 year fixed-term Lecturership in Pharmacology at University College London (2002-2005); this is the premier Pharmacology department in the UK and it offered an excellent opportunity to develop his teaching expertise. Gary took up his current Lecturer in Pharmacology position at the Reading School of Pharmacy (RSOP) in Sept 2005 and became a Senior Lecturer in 2008. Since joining the RSOP, he has established an Electrophysiology Group, bringing this important technique to Reading’s research portfolio. Gary has continued his internationally competitive research at RSOP, securing major Wellcome Trust, BBSRC and Royal Society Project Grant. He has also attracted Pharmaceutical industry funding, being Co-PI on grants from UCB on a substantial on-going funding from GW Pharmaceuticals to investigate roles of cannabinoids in epilepsy. Gary’s funding supports PDRAs and a number of PhD students. He has published regular research papers/reviews in international journals and presented numerous invited, oral and poster presentations at national and international conferences. Gary has a major commitment to Teaching within the RSOP, he is Director of Undergraduate Studies on the MPharm. Finally, he has a major role in Administration in the RSOP, being Director of the MPharm programme and a member of the Pharmacy Management Board.
Professor Gavin Brooks BPharm, PhD, MRPharmS, FAHA
Professor Gavin Brooks is Dean of the Faculty of Science and Professor of Cardiovascular Research at the University of Reading. He graduated with a first class honours degree in Pharmacy (1984) and obtained a PhD in the areas of organic chemistry and pharmacology (1988) from The School of Pharmacy, University of London. He registered as a Pharmacist with the RPSGB in 1985 and has remained an active member since that date. In 1988, he joined the Imperial Cancer Research Fund Laboratories in London as a post-doctoral research fellow before being recruited (1992) as a Group Leader to the 5*-rated Department of Cardiovascular Research, The Rayne Institute, St. Thomas' Hospital, London where he began focusing on the mechanisms that control physiological and pathophysiological cardiovascular cell growth. In 1997, he joined Prolifix Ltd. as head of their cardiovascular programme and in 1999 returned to academia where he now is Professor of Cardiovascular Research at the University of Reading. In 2001, he was elected a Fellow of the American Heart Association and in January 2004, he became founding Head of the new Reading School of Pharmacy. In 2008, he was a founding member of the highly successful Institute for Cardiovascular and Metabolic Research (ICMR) that is based at the University and in August 2008 he was made Head of the School of Biological Sciences at the University of Reading. He was elected Dean of Science in August 2010. Amongst a number of academic external appointments, he has served as Chairman of the International Pharmaceutical Federation (FIP) Special Interest Group on Pharmaceutical Biotechnology and currently is Chairman of the South East Universities Consortium for Biopharma Skills
Jane Penson
Jane has been a training consultant since April 1997, specialising in writing skills such as report and proposal writing for scientists, bankers, researchers and consultants. She advises companies on communications strategy and house style.
She loves words. Her training helps people to use written English to engage, persuade, inform and interest their readers. The focus of her workshops can be on planning and structuring clear reports, winning bids with excellent proposals or simply using language correctly, concisely and clearly.
Delegates come away from Jane’s sessions with new enthusiasm to tackle writing tasks because she provides a clear process that they can follow or adapt. She takes great trouble to involve everyone and delivers on her promise that every question deserves a serious answer.
Jane’s clients include banks, law firms, large consultancies, research organisations and pharmaceutical companies. She has international experience, having delivered training in South America and the United Arab Emirates as well as in various parts of Europe. Her background includes a languages degree from Cambridge and an MBA from Henley Management College.
John Cooper BSc, C.Sci, CChem, FRSC, MCQI, CQP
John began his career in the pharmaceutical industry in 1976 in analytical chemistry laboratories and moved on to manage various quality functions. During this time he was responsible for a wide range of activities including wet chemistry, intermediate and finished product testing and Vendor Audits. In 1989 John moved to Packaging Quality Assurance and was the main site QP for ten years. In 1999 he moved into New Product Introduction and was responsible for leading multi-disciplinary teams transferring a number of global products from R&D to packaging, and in 1999 this role was combined with an Artwork and Design group which John led for five years until December 2005. John then led a Packaging Manufacturing Support organization involved in Packaging transfers and new business introduction for 2 years before re-joining Quality Assurance as Quality Systems Manager which he led for 2 years. John now runs his own consultancy business offering a wide range of services to the Pharmaceutical industry including vendor auditing and acting as a Contract Qualified Person for UK and US based companies.
Trevor Coomber
Trevor is a Pharmaceutical Development Consultant with over thirty years experience in the industry particularly in analytical development of new chemical entities. He has lectured on analytical topics throughout Europe for eight years and has also provided expert advice on developability, stability testing and registration issues. He spent six years as a senior Project Team leader and Analytical Science Manager in GlaxoWellcome and GSK. Prior to that he was a team leader in the analytical Development Laboratories in Wellcome where he developed and validated analytical methods and served on project teams including leading the Technical Development (CMC) of Valtrex Tablets from the molecule to the market place.
Brian Hammond BSc, CChem, MRSC
Thirty-eight years experience in the industry initially in Analytical development moving on to Quality Compliance and System Validation, followed by fifteen years experience in the training and consultancy arena.
Contracts and areas of involvement have included: -
Development of training material, both classroom and e-learning packages, to support the Quality Management System of a major Pharmaceutical Company. Also support during gap analysis following implementation of the QMS.
Development and delivery of cGMP training packages covering a number of disciplines. This included development of suitable packages to be delivered to engineering staff, office and support staff.
Development and delivery of training material covering a number of different Quality areas. These include Good Documentation Practices, Corrective & Preventive Action (CAPA), Change Control and cGMP aspects of Engineering Permits to Work.
Dr Christopher Burgess
Christopher is an internationally recognized expert in the qualification and validation of instrumentation and systems, analytical method development and validation and the statistical interpretation of data. In addition he has extensive experience in quality systems design and development for the whole supply chain and has acted as a Qualified Person within the EU for more than 25 years. He has over 35 years experience in senior management and consulting positions within the pharmaceutical, biopharmaceutical and medical device industries including 20 years with Glaxo in Analytical R & D, Quality Control and Quality Assurance.
Christopher has MSc and PhD degrees from Loughborough University in Analytical Chemistry. He is a Chartered Chemist (CChem), a Fellow of the Royal Society of Chemistry (RSC), a Chartered European Chemist (EurChem) and a Chartered Scientist (CSci), a qualified ISO Guide 17025 assessor and an Advisory board member for the European Qualified Person Association.
He has been elected to serve on the USP General Chapters-Chemical Analysis Expert Committee for 2010 – 2015. Recently he has been invited as a visiting professor at Strathclyde Institute of Pharmacy and Biomedical Sciences at the University of Strathclyde.
Dr Burgess has published over 80 papers and books in analytical chemistry and analytical science.
Ciarán M Brady
Ciarán has over 25 years experience in Supply Chain/Materials Management in the Pharmaceutical, Healthcare and Drinks industry. He has worked as Head, Supply Chain Management, International Logistics & Demand Manager, Materials Manager, Purchasing and Quality Manager, working with major multi-national companies (e.g. Glaxo, Schering-Plough, Oral-B Laboratories). He was involved in two green field start up's and five worldwide plant consolidations. Working at a Senior Management level in Finished Pharmaceutical Manufacturing & Distribution, he has extensive working knowledge of FDA and MHRA/IMB requirements, and all aspects of GMP & GDP.
He has worked extensively since starting up PLS Pharma Logistics with Pharmaceutical Wholesalers, Manufacturers/ Logistics companies and assisted these companies in all aspects of Good Distribution Practice and Supply Chain Management - including preparation for licence applications, inspections and remedial work after regulator inspections, and services including audits, mock recalls, SOP reviews and improvements.
PLS also work with partners to provide temperature monitoring services for client companies.
- Former Director and Board member of the Irish Institute of Purchasing and Materials Management (IIPMM) and a member of the Institute for 18 years.
- Member of Supply Chain Institute, the Institute of Management Consultants and Advisers Ireland, (AIMCA) and a committee member of the Independent Consultants Group.
- Lectured for 3 years on IIPMM Diploma course, and has lectured for the National Institute for Logistics and Transport.
- Currently lectures for the Irish Management Institute on its Supply Chain Management Program and Pharmacareers & Frank Bagshaw Ltd on all aspects of GDP, and the Pharmaceutical Industry.
- He is a founder and Associate Partner of Pharmacareers.
David Wilson BSc (Hons) CBiol MIBiol
Since graduating in 1973, David has been employed exclusively in the UK pharmaceutical industry, gaining extensive experience in the development, production and GMP's of sterile products at Fisons as Company Microbiologist (Holmes Chapel).
In 1989, David joined Waverley Pharmaceutical Ltd as Director in charge of QA, QC, Process Development, Product Development and Regulatory Affairs, and in 1993 formed Kaster Bioscience Ltd which manufactured microbiological media for the pharmaceutical industry, specialising in systems for validated environmental monitoring, and providing consultancy to the pharmaceutical, cosmetic and food industries concerning microbiological standards, process design and aseptic processing, with a contract microbiological analytical and development service. He has published widely on sterile production technologies, Pharmaceutical cGMP’s and the Blow Fill Seal process and is a QP under EC Legislation.
David now works as an independent consultant in the pharmaceutical industry, specialising in sterile production, cGMP, pharmaceutical microbiology and process installation and validation.
John Dolman C Sci, CChem, FRSC, CQP, FCQI, MCMI
John has held senior Quality roles in several of the major companies and is a former chairman of the UK Royal Society of Chemistry’s panel of Qualified Person (QP) assessors. He has wide experience of the development, manufacturing, quality control and regulatory aspects of many dosage forms gained from spending over 40 years in the Pharmaceutical Industry. John is now one of the key tutors on RSSL Pharma’s QP Training Programme.
Keith Dobson MSc, CChem, FRSCFIQA
Keith Dobson has held senior Quality roles in several of the major pharmaceutical companies and is a former QP assessor for the Royal Society of Chemistry. He has a wide experience of the development, manufacturing, quality assurance and regulatory aspects of both API's and all ‘dosage forms and was a member of EFPIA's Expert Working Party for the development of the ICH Q7A Guideline.
Martyn Cobb
Martyn has over 40 years experience in the Pharmaceutical Industry, during which time he has held a variety of positions from Laboratory Management in the UK through to Manufacturing Director in the USA.
He began as a validation technician gaining experience in manufacture of a wide range of pharmaceutical products including sterile products, biological products, tablets and liquids. From there he progressed to quality control laboratory management where he stayed for 7 years. His next promotion led him to Quality Assurance where he became head of audit services for a multinational company for 10 years. This involved preparation for inspection and ensuring compliance of facilities as well as hosting regulatory inspections for the organisation. This work also involved extensive travelling to the USA and Europe performing inspections of other facilities within the organisation. A major part of this role was co-ordination of a global supplier audit system for key suppliers and contractors.
During the last 10 years, Martyn has offered consultancy to organisations in the Pharmaceutical and Medical Device sectors, giving extensive reports and advice on the compliance status of organisations, often following regulatory censure. Martyn has also held some interim management positions in pharmaceutical and medical device organisations in quality and regulatory affairs.
There has been a large element of developing and delivering training to people within those industries, giving compliance training against both international and local regulations as necessary.
Martyn is still a practitioner in many aspects of pharmaceutical and medical device inspection and audits around the globe on behalf of international consultancy and numerous organisations based in Europe and the USA.
Matthew Scotney
Matthew started his career in Biopharmaceuticals as part of a “year in industry” with Celltech (now part of the UCB family) as a validation year in industry student, working with specifically within the fields of cleaning and sterilisation validation. Following the completion of this year Matthew took up his place at Surrey University (Guildford) to study Microbiology and Biotechnology during which he work within the toxicology department for Clairol US focusing on computational toxicology and the support of regulatory dossiers supporting the safety of Clairol products. Following the successful completion of his degree Matthew worked for Delta Biotechnology in both a QA validation and Quality Assurance role. In these roles Matthew continued to learn about the practical application of Validation and Quality Assurance in the Biopharmaceutical field with specific focus on sterilisation and cleaning validation, autoclave validation and investigation into manufacturing deviations. In 2001 Matthew moved back to Celltech (now Lonza Biologics) and for the last 8 years has held various roles within the Lonza QA organisation. For the last 4 years Matthew has been responsible for the QA Lot Review and Lot Disposition department acting as the primary dispositioner for all Lonza products, both Clinical and Licensed releasing around 50 batches of various biopharmaceutical bulk active pharmaceutical ingredients (API) products (mainly Human Antibodies for mammalian cell culture) per year. In 2007 Lonza were compelled to apply for a Manufacturing License for our “in market” APIs and more recently in 2009 an investigational medicinal product licence and as a result Matthew has worked towards obtaining QP status while working with contract and in house QPs to ensure that the policies and procedures utilised by Lonza Biologics for batch release were appropriate. During this time he was also responsible ensuring the QPs employed by Lonza were sufficiently familiar with Biopharmaceutical product to carry out their duties.
Peter Willis
Peter has over 30 years experience in the industry, 19 as a consultant, with the remainder spent in site and corporate quality assurance roles for SmithKline Beecham, Zeneca and GlaxoWellcome where he was responsible for the preparation for and management of regulatory authority inspections. He is a microbiologist by training and has experience of the manufacture of a wide range of dosage forms.
Rick Bastin CChem, MRSC
Rick has worked within development functions in the pharmaceutical industry for over 20 years. During this time he has worked in scientific and managerial capacities in both big pharma and contract development organisations. His experience includes the formulation and processing of wide range of pharmaceutical dosage forms (including solids, liquids, parenterals and semi-solids) taking products through from discovery to commercialisation. Other areas of experience have included preformulation, process validation and scale-up to commercial manufacture.
Rick Maddock MRSC
Rick has over 30 years experience in the pharmaceutical industry having worked in Quality and Production departments concerned with a wide range of dosage forms. He has considerable international experience having been involved in manufacturing and validation projects in many overseas territories. For several years Rick has been a practising consultant focusing on Quality Systems, auditing and validation activities.
Sue Mann
Sue Mann has extensive experience in the Pharmaceutical Industry spanning over 25 years, in roles including production support, clinical trials supply, technical management and QA. Sue has worked for many types of company, including multinational, national (niche products, contract acceptor), Japanese and virtual, latterly as Vice President of International Quality Assurance at Shire Pharmaceuticals, responsible for all quality, GMP and related aspects for both development and marketed products. She also spent approx 10 years as a Partner and GMP consultant, principally auditing and training, both in the UK and travelling extensively overseas.
Sue is a Pharmacist, a Qualified Person and a member of both the Chartered Quality Institute and British Association of Research QA (BARQA). She is also a QP Assessor working on behalf of the UK MHRA, representing the Royal Pharmaceutical Society of Great Britain.