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The IAGT Team
Teamwork is what makes things happen in your company and ours.
At IAGT we believe in using both strategic and practical hands on industry experience to ensure our clients receive the results they are looking for.
IAGT understand how to deliver pragmatic solutions in order to satisfy regulatory requirements whilst getting real value out of business processes and performance.
The IAGT Directors personally work with all clients and ensure any supporting Consultants deliver the same levels of expertise and practical value expected in today's pharmaceutical industry.
"IAGT's knowledge, experience and technical ability is second-to-none"
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Ivan Diamond
Managing Director
Ivan Diamond is a former Design and Project Manager with over 20 years
of experience in dealing with pharmaceutical design, quality and validation projects and manufacturing facilities. He
is an expert in the field of GMP computer systems across pharmaceutical laboratories, production and business environments
and has established effective training and communication programmes to improve company compliance and performance.
He has extensive experience of dealing with GMP & Quality Critical Electronic Records/ Signature compliance, including
21 CFR Part 11 and is a leading expert on the effective application and implementation of the latest GAMP 5
publication. Ivan holds a Masters Degree in Business Administration and Engineering qualifications in building
services and electronic engineering. Prior to founding IAGT, Ivan worked for GlaxoSmithKline.
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Steve Fairchild
Director
Steve Fairchild has worked both as a Manager of the Inspections Sector in the European
Agency for the Evaluation of Medicinal Products (EMEA) as well as a Medicines Inspector with the UK Pharmaceutical
Regulatory Authority (the MCA, now the MHRA). In addition, he has worked in both Production and Quality Assurance
roles for leading multinational pharmaceutical companies, including GlaxoSmithKline.
He worked with the heads of the GMP inspectorates from the European Union (EU) member
states and lead the EU team for the implementation process for Mutual Recognition Agreements. In additon he
participated as a member of the ICH Expert Working Group that developed the internationally harmonised GMP Guidance for
Active Pharmaceutical Ingredients.
Steve holds a degree in Pharmacy and is a registered member of the Pharmaceutical Society in the UK. In May 2004
he was awarded the FDA Commissioners Special Citation Certificate in recognition of his important contributions in the
finalising of ICH Q7A (GMP for Active Pharmaceutical Ingredients).
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Nigel Halls
Director
Nigel Halls is a healthcare quality specialist with particular interests and specialist knowledge of sterile products, aqueous non-sterile products, sterilisation technologies (steam, dry heat, radiation and ethylene oxide), water systems and all aspects of validation. Since founding IAGT along, with Ivan Diamond, he has been extensively involved in the preparation of pharmaceutical manufacturing sites for FDA and EU inspection and has provided trouble-shooting and improvement support to large and small companies in the UK, Europe, India and the Mid-East. Nigel is an acknowledged expert in pharmaceutical microbiology and sterilisation; he has published several books and has been a frequent contributor to the scientific literature on safe pharmaceutical manufacture, including being a co-author of PDA's controversial 2007 revision of Technical Report No 1 on Steam Sterilisation. Nigel has been involved in Qualified Person training since 2002 and he has participated in the training of national inspectorates in three European countries. He is the author of distance learning modules on sterile product and their manufacture for the University of Manchester's PIAT, PEAT and PMAT programmes and has written a significant number of scripts for MVI's DVD pharmaceutical industry training programmes. Prior to taking up consultancy Nigel was with GlaxoSmithKline.
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Edel Fitzmaurice
Consultant
Edel
has a proven track record of achievement in the Pharmaceutical industry including project management, new product launches, compliance, quality
assurance, regulatory inspections and laboratory/manufacturing operations.
She has extensive experience in the areas of developing and implementing quality systems, vendor management, Risk
Assessments, HACCP microbiology and auditing as well as manufacturing and QP experience in Oral Dosage, Inhalations,
Steriles, Herbal, Homoeopathic Blood and Tissues and Critical Nutrition.
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