Marika Lundin

Marika works both as trainer and consultant at Key2Compliance, with a GMP and Pharma focus. She has a scientist background (PhD in Virology) and have more than 10 years of experience in GMP. She has worked in a variety of roles in different industry segments, eg Pharma industry (eg validation, qualification, production processes, aseptic assurance), […]

Kristine Frederiksen

Kristine Frederiksen, DKMA

Medicines Inspector at Danish Medicines Agency (DKMA) Kristine is a Medicines Inspector at DKMA, she is specialized in inspection of companies working under GMP, GDP and CAN standards. She has been at the Danish Medicines Agency for 6 years. Before that she worked in different companies in the pharmaceutical industry for +10 years. She holds […]

Thomas Noe Vestergaard Pedersen

Thomas Noe Vestergaard Pedersen, DKMA

Team manager and Medicines Inspector at Danish Medicines Agency (DKMA) Thomas is a Team Manager for a team of 18 medicines inspector at DKMA. He has been at the Danish Medicines Agency for 9 years. Before that, he worked for +10 years in different pharmaceutical companies. He holds a Ph. D. degree in Exotoxicology and […]

Patrick Coppens

Patrick Coppens

Expert on Process Design Expert on sterile process Expert to develop tools or robot under sterile condition Expert on formulation (CIP/SIP) Expert on visual inspection on glove and sleeve Expert to optimize process Expert on integrity filters Good knowledge about Regulatory Good knowledge about Data integrity

Laurent Merli

Laurent Merli

Ph.D. in Chemistry Science Expert of Sterile Manufacturing & Radiopharmaceutical Drug Products After a master’s degree at University of Liège (Belgium) with a thesis in the Organic Chemistry Department, Laurent got a PhD in chemistry at the same university with a thesis in the Radiochemistry Department (analytical study of radioactive material). With more than 25 […]

Magnus Jahnsson

Magnus Jahnsson

Magnus Jahnsson is Director Training and Courses at Key2Compliance. He has worked in the pharmaceutical industry for almost thirty years. During this time, he has worked both for the industry and for a regulatory authority. He has held positions in Research and Development, Manufacturing Operations, Quality Assurance and Regulatory Affairs, working both as a manager […]

Nina Bjork

Nina Björk

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 […]