Maria Axelsson

Maria is a Senior Trainer at Key2Compliance. She has over 20 years of experience in the Pharma and Medtech Industry. She has worked extensively with Quality Management Systems especially for Pharma and Medtech as well as for IVD and the food industry. Maria has held roles mainly within QA (eg validation, qualification, Deviation and CAPA […]

Sara Falkenklint

Sara Falkenklint

Sara Falkenklint is a trainer and consultant at Key2Compliance®, with more than 15 years of experience within GMP and Pharma.  She has held both laboratory, specialist, and manager positions, and has solid experience from QA, QC, biological raw material release and process improvement. Sara is skilled in supplier management, inspections, and trainings. She has also […]

Marika Lundin

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. […]

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