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 […]

Elodie Pastre

Chemical engineer – Founder of Theraxel-Point Forty Five Contamination control specialist. Theraxel-Point Forty Five is a Company specialized in consulting, technical assistance, regulatory audits and training around the control of the chemical risk, Microbiological, particulate and pyrogenic for non-sterile, sterile and biotechnological pharmaceutical industries as well as related industries such as cosmetic industries. Elodie Pastre […]

Annick Niclas

Coach, instructor and consultant Cabinet ACE Performance, Saint Hilaire sur Erre, France Annick NICLAS has more than 25 years’ experience in GMP and Quality Management System helping pharmaceutical and medical device organizations to comply with GMP/QS-expectations. Annick’s objectives are to enhance workforce knowledge and motivation and to promote a correct attitude towards quality. Her skillset […]

Emmanuel Gourvil

Operational Quality & Industrial Processes Expert, Theraxel – Point Forty Five Theraxel-Point Forty Five is a Company specialized in consulting, technical assistance, regulatory audits and training around the control of the chemical risk, Microbiological, particulate and pyrogenic for non-sterile, sterile and biotechnological pharmaceutical industries as well as related industries such as cosmetic industries. Mr. Emmanuel […]

Christophe Gamblin

Cross Contamination Expert, Theraxel – Point Forty Five Theraxel-Point Forty Five is a Company specialized in consulting, technical assistance, regulatory audits and training around the control of the chemical risk, Microbiological, particulate and pyrogenic for non-sterile, sterile and biotechnological pharmaceutical industries as well as related industries such as cosmetic industries. Mr. Christophe Gamblin is working […]

Pierre Devaux

Pierre Devaux

Microbiologist Pharmacist – Co-Owner and Scientific Director of Theraxel Expert Manufacture Of Biotechnological, Biological & Sterile Medicinal Products and Cross Contamination Quality Risk Management, Biological Control & Contamination Control Strategy, Cross Contamination Control Strategy and Cleaning Validation International Good Manufacturing Practices He has the following experience: 6 years as responsible for the quality control laboratories […]

Cyrille Michaud

Based in Aix-En-Provence (France), Mr. Michaud is a seasoned information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was Project Director from 2009 to 2011 at Olea Medical – a medical imaging start-up. His main achievements were the ISO 13485 certification and the CE Mark and […]