Michael Gamlen
Michael is managing director of Pharmaceutical Development Services Limited, a Guildford UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a 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 Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.
Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.
David Inglis
David is director of Ulverston GMP Consulting Limited, 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 PhD in enzyme chemistry (affinity chromatography).
With over 30 years experience in quality assurance in the pharmaceutical industry, David has 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.
David 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.
David 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, David received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.
Hedley Rees
Hedley is managing director of Pharmaflow Limited and had many years in the pharma and biotech industry working with high profile biotech and emerging specialty pharmaceutical companies to bring new 'molecular' entities and re-profiled compounds through development stages into full scale commercial launch. He has been a key contributor to trial progression and commercial launch across all phases of development in multiple territories and global markets.
Hedley was responsible for managing global supply chains in big pharma companies such as Bayer and Johnson & Johnson. Here, he built a wide competency base in all the disciplines of supply chain management, implementing and using state-of-the-art information systems enablement. He holds an Executive Master's in Business Administration from Cranfield University School of Management, a degree in production and industrial engineering from the University of Wales and is a full corporate member of the Chartered Institute of Purchasing and Supply (CIPS). Hedley sits on the Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.
Roland Colicott
Heading up the ChalPharm Consultancy, Roland provides assistance to the pharmaceutical industry in the areas of chiral analysis, polymorphic characterisation, stability studies, chemical analysis in a GMP environment, specifications and all aspects of international CMC documentation. He also runs training courses to cover many areas of analytical chemistry, particularly in chromatography, chiral and polymorphic analysis. He has served as an expert witness and consulted in trials in Canada, UK, South Africa and Germany.
Before founding the ChalPharm Consultancy in 2005, Roland was analytical section manager at OSI Pharmaceuticals responsible for delivering validated analytical chemistry methods and CMC documentation for OSIs regulatory submissions. In this role, he was responsible for collating and interpreting data from a wide range of analytical techniques, acquired in-house or at contract, for the characterisation of new compounds. There he also gained valuable international experience, working closely with regulatory and clinical groups as well as manufacturing and analytical contractors in Asia, Europe and the US.
Roland began his career in physical chemistry at Glaxo Group Research and originally specialised in chromatography, introducing the use of chiral HPLC columns to resolve enantiomers. He gained a PhD from his research into novel silicon-based chiral derivatisation reagents for HPLC, GC and NMR analysis. In 1998 he joined British Biotech, where he became involved in many other areas of analytical chemistry including polymorphism in pharmaceutical products. As Group Leader, he managed British Biotech's QC procedures, stability testing and the analytical development of its NCEs.
Chris Barnett
Chris is director of CMBarnett Pharma Services Limited, an independent GMP and compliance consultancy. 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.
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.
Pauline McGregor
Pauline has 20 years experience working for pharmaceutical companies and contract testing laboratories in both Canada and the UK.
She completed her honours degree in Scotland on a part time basis while employed full-time. She left the industry to pursue her PhD in photo organic chemistry where she also taught analytical techniques to undergraduate students. On completing her PhD in 1995, she travelled to UWO in London, Ontario, Canada to complete her post doctoral studies. She is an experienced trainer and has been delivering cGMP and validation training for the past 15 years. She is rated very highly as a presenter.
Since then she has worked as a validation specialist at Pfizer, manager of research, development and validation at SGS Life Sciences, a consultant to the pharmaceutical industry and has taught analytical R&D, method validation, GMP and related quality systems courses across Canada, in the US and China.
Throughout her career, Pauline has identified a lack of shared knowledge between manufacturing, quality control, R&D and quality assurance sectors in the healthcare industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonised understanding.
Pauline is also a member of The Royal Society of Chemistry, UK and listed on the RSC Directory of Consultants.
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. Ralph has over 25 years experience in the industry as a scientist, project manager and learning & development specialist.
John Faulkes
John is Director of Team Communications 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.
Ron Scott
Ron is a director of chemistry services for Pharmaceutical Development Services and is a consultant in all aspects of the development of chemical processes and manufacture of active pharmaceutical ingredients. He has a first class honours BSc in chemistry and a PhD 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.
