If you have a background in quality operations and QP radiopharmaceuticals, have acted as an auditor at pharmaceutical companies for starting material suppliers, and would like to join our expert auditors team, send us your CV and a cover letter to earl@eanm.org
The Shared Audit and Supplier Assessment Initiative (SASAI) is setting new standards across the globe of how audits are being done. Community-based and customizable, the key to success of our audits are our auditors. SASAI’s auditors are its greatest asset, and with a good reason. It is only their determination and commitment that delivered the SASAI programme which serves the nuclear radiopharmacy community needs. SASAI’s goal is to generate long-term relationships with the suppliers and the community.
The SASAI auditing team consists of at least one fully qualified, certified auditor who is supported by additional Subject Matter Experts (SMEs) which are chosen based on the needs of the audit at hand. Meet the SASAI expert auditors who made this programme possible.
Prof. Dr. Marianne Patt is the head of radiochemistry at the University of Leipzig, Germany, also a qualified person (QP) according to both European and national (German) regulations, deputy qualified person for pharmacovigilance (QPPV) according to both European and national (German) regulations and has a qualification as a GMP auditor. Prof. Dr. Patt is a chair of the SASAI working group, the chair of the Radiopharmacy Committee of the EANM, and a member of several professional societies and working groups nationally and internationally. Prof. Dr. Patt has an active GMP expert auditor certificate. For a full list of SME audits and CV click here.
Dr. Rainer Suchi is the former director of quality operations and QP radiopharmaceuticals at GE Healthcare Buchler, Braunschweig Germany. Dr. Suchi is the lead auditor for the proof-of-concept ABX audit. He is a member of several professional societies and working groups, as the Working Group on Radiochemicals and Radiopharmaceuticals of the German Society of Nuclear Medicine and the Expert Group on Radiopharmaceuticals of the German Pharmacopoeia, to name a few, besides some other nationally and internationally. Dr. Suchi has an active GMP expert auditor certificate. For a full list of SME audits and CV click here.
Dr. Almut Walte is a radiopharmacist, qualified person and the head of quality qontrol and quality assurance at the department of nuclear medicine (radiopharmaceutical chemistry), at the Medical School Hannover, Germany. Dr. Walte is also an active member of the working group “Radiopharmaceuticals” on the Committee of Pharmaceutical Chemistry at the German Phamacopeia. For a full list of SME audits and CV click here.
Dr. Cécile Bourdeau is the deputy director a direction board member at ARRONAX Cyclotron, GIP – Nantes (France), production and research activity of innovant radioisotopes, radiochemicals and radiopharmaceuticals product. Ms. Bourdeau is responsible for pharmaceutical affairs (QA & RA) and radiochemical and GMP production. For a full list of SME audits and CV click here.