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

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

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 […]

Daniel Stenströmer

Daniel Stenströmer

Daniel is a Quality Management System specialist with 17 years of experience from biotech and medical device/IVD industry. He started his career as a project leader for pre-clinical studies at Micro Active Protein in Sweden AB in Gothenburg, Sweden in 1998 after studies in chemical engineering at Uppsala University, Sweden. After one year he Ieft […]

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 […]

Katarina Wendsjö

Katarina Wendsjö is a civil engineer who has gone from chemical engineering to personal chemistry. More than 20 years in the private business world have given her experience from several different leadership roles such as manager, project manager and competence area leader. Since 2008, Katarina has been working with leadership and organizational development as well […]