Nina Bjork

Nina Bjork is passionate about helping organizations realise and overcome the barriers to sustainable long-term growth. She brings over 20 years’ experience across a range of pharmaceutical companies and from the Regulatory Authorities. She has worked in small, medium and large pharma biotech companies across the product lifecycle for a wide range of dosage forms. […]

Laurence O’Leary

Laurence is Founder of ValidEire ApS and has over 20 years working in Pharmaceuticals and Medical Devices. Laurence has a long‐ track experience in QA, Compliance, Cleaning Validation and Process Validation roles. He presently works as a Contract Validation Specialist. He is a seasoned trainer inhouse for all of his previous clients in Compliance subjects […]

Ioanna-Maria Gerostathi

Ioanna-Maria works as a Qualification and Validation Consultant for the Pharmaceutical Industry. She has five years experience in cleaning validation, equipment, facilities and utilities qualification and as well as aseptic manufacturing and process validation. She has worked in Quality Assurance, Validation and Engineering in the Pharmaceutical Industry. She has set sampling plans and trained people […]

Shahbaz Sarwar

XMHRA Consultants Ltd. A graduate in BSc Biomedical Science, Shahbaz worked in Biotechnology for a Contract Manufacturer of Active Pharmaceuticals Products (API’s) as a Production Manager before joining the MHRA as a GDP Inspector. He spent a very enjoyable and rewarding 5 years as a GDP Inspector conducting hundreds of inspections of pharmaceutical wholesale distributors […]

James L. Vesper

Dr James L. Vesper designs and develops instructional courses and workshops for the pharmaceutical industry. He established and is president of the firm, LearningPlus, Inc., and has had more than 25 years’ experience in the pharmaceutical industry. Dr Vesper worked eleven years at Eli Lilly and Company, Indianapolis. His last assignment was as Project Leader […]

Energy Kristina Hansen

Energy Kristina Hansen is the founder of MilCor Consulting. She is an accomplished speaker and presenter who is known for her warmth, humour, and energy in her motivational presentations. Energy Kristina is also an annual guest lecturer on the topic of ‘Changing Undesirable Behaviours’ at the University of Copenhagen (LIFE) since 2013. She has trained […]

John Y. Lee

John Y. Lee is Executive Director of Pharmaceutical Compliance Associates, an organization specializing in pharmaceutical compliance consulting, auditing, quality assurance, validation, and training. Prior to joining PCA, Mr. Lee held positions as Quality Assurance and Quality Control Director at Altana, Inc., Melville, New York; Quality Assurance Manager at Organon, Inc., West Orange, New Jersey; GMP […]

Peter L. Knepell

Dr Pete Knepell is president of Peak Quality Services in Colorado Springs, CO. Since 1988 he has trained thousands of professionals in quality systems and quality improvement methodologies. His past clients include: several defence agencies, the Canadian Red Cross, Sony, Corning, Texas Instruments, Xerox, Hewlett Packard, Heritage Valley Health System, GlaxoSmithKline, Amgen, GE Healthcare, Roche […]

Annette Hillring

Anette has been an independent regulatory affairs consultant since 1998. Prior to consulting, she was Director, Regulatory Affairs, for Critikon, a Johnson & Johnson Company, where she worked with cardiovascular monitoring devices since 1987. She has over 20 years’ experience in regulatory affairs, compliance and clinical affairs with prior experiences in the implantable cardiovascular and […]

Robert J. Hayes

A Chartered Mechanical Engineer, Bob has worked in the Pharmaceutical Industry for over thirty years in operational and support roles with leading international companies. Bob has also worked in other sectors, including aerospace, precision engineering, FMCG, insurance, construction and brings with him a wealth of expertise practical experience and best practice. Bob is Vice Chair […]