Pharma Training Services

Our Speakers Faculty

	Dr Michael Gamlen Michael is Managing Director of Pharmaceutical Development Services Ltd, a Guildford-based technical consultancy. Dr Michael Gamlen has over 30 years experience of tablet development. Awarded a First Class Honours degree in Pharmacy, specialising in Pharmaceutical Engineering, he studied for PhD at Nottingham University. He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Ltd and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional courses for many years.

	Dr David Inglis David is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs. He has a Ph.D. degree in enzyme chemistry (affinity chromatography). During more than 29 years in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance. He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials. Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. He has extensive experience of being the lead spokesman during major regulatory audits. Dr Inglis is a specialist in cGMP training and QA system improvement. His flagship improvement package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.

	John Faulkes John is director of TeamCommunications Development, and is an expert in organisation and team development, specialising particularly in cross-function working /matrix organisations. He has over 15 years experience working with the pharma/biotech sectors as well as in general manufacturing, sales and the public sector.

	Dr Ralph White Ralph is director of PPMLD, which provides consulting as interim project management as well as learning and development work for the pharmaceutical/biotechnology industries. has over 25 years experience in the industry as a scientist, project manager and learning & development specialist.

	Dr Ron Scott Ron is a Director of Pharmaceutical Development Services and is an consultant in all aspects of the development of chemical processes and manufacture of active pharmaceutical ingredients. He has a First Class honours B. Sc. in Chemistry and a Ph. D. in Synthetic Organic Chemistry and is a Fellow of The Royal Society of Chemistry. During a 25 year career he has worked in leading contract manufacture and contract R&D organisations including Oxford Asymmetry and Almac Sciences where he held senior management positions in technical operations up to Vice President level. He has had responsibilities for New Product Development, Process R&D, Process Safety, Quality Control, Quality Assurance, Production and Environmental Compliance. He specialises in the design and optimisation of robust and economical chemical processes for the supply of new chemical entities for clinical development and subsequent commercial manufacture. A particular niche area of expertise is the design and safe use of facilities for handling highly potent active pharmaceutical ingredients, typically for oncology applications.

	Mr Chris Barnett Chris is Director of Quality and Compliance at Pharmaceutical Development Services, a technical consultancy based in Guildford UK. Chris has a talent for coaching and explaining complex regulations in a straightforward manner. He recently spent time in India patiently explaining regulatory procedures to people unfamiliar with European practices. Chris is an expert in quality management, technology transfer and new product introduction and specialises in Quality Management, Technology Transfer and New Product Introduction. Chris has a background as an analytical chemist and over 20 years experience in QA roles, with the Wellcome Foundation and GlaxoSmithKline. He has had QA management posts in India and Mexico, as well as new product introduction project management roles in pharma manufacturing. Chris ran his own consulting company for several years prior to joining PDS in 2002. Chris graduated from Cambridge in natural sciences, with an MSc in analytical chemistry, and subsequently an MBA from Greenwich University.

	Andy Langler Andy Langler has worn several “hats” in his professional life and has more than 20 years experience in the pharmaceutical, agrochemical, not for profit and publishing environments. This includes a number of formal and informal training and developments roles. Throughout this time he has worked with many people from all levels of organisations to help them reach their maximum potential. Andy has led, been involved with and written programmes for many types of development initiatives from board level change management to shop floor communication skills. His range of training skills covers a wide range of areas including: interpersonal & communications skills; management development; change management; IT strategy and getting the most out of IT. His approach is based firmly on understanding the learner’s perspective and by means of clear presentation of information, abundant opportunities for questions and, where appropriate, hands-on exercises, together with immediate feedback, make concepts easy for participants to grasp and then apply.

	Prof Graham Buckton Graham is Head of Department of Pharmaceutics at the School of Pharmacy, University of London, and Chief Executive Officer of Pharmaterials Ltd, a CRO with skills in (amongst other things) study and stabilisation of the amorphous form. He is the immediate past chair of the Chemistry Pharmacy and Standards sub-committee and was a member of the Committee on Safety of Medicines, he is a British Pharmacopoeia Commissioner and chairs the Excipients Committee. He has received a number of research awards and has published over 150 papers in this field. He is editor of the International Journal of Pharmaceutics and on a number of other editorial boards.

	Dr Simon Gaisford Simon is Lecturer in Pharmaceutics at the School of Pharmacy, University of London. His PhD was related to modelling of calorimetric data for stability studies and he has subsequently worked on a wide variety of systems using many different thermal methods. this year he was awarded the Sunner Award by the US Calorimetry conference for his contributions to thermal chemistry.


	Paul Titley Paul is the CEO of R5 Pharmaceuticals Ltd. Paul has over 30 years of experience in the development of pharmaceuticals. Originally with Wellcome, GlaxoWellcome and later into the contract sector with Quintiles and then Encap (General Manager). He specializes in process development and validation and has lectured on these subjects since 1983. R5 Pharmaceuticals is a new contract pharmaceutical development company based at BioCity, Nottingham, UK. R5 has been set up by a team of individuals with many years experience in the science and management of the contract development and manufacture of clinical trial materials. R5 will develop and manufacture clinical materials including tablets, capsules and injectables from its new facilities.