Capabilities Development for Sterile Manufacturing

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Presented by

Dr Mauro Giusti, Senior Director, Site External Network at Eli Lilly & President, PDA Italy Chapter

About this talk

Eli Lilly realized that the professionals (chemists, pharmacists, engineers, biologists, biotechnologists, etc) in charge of the Flow Teams and Process Teams (providing oversight to sterile manufacturing operations) required to strengthen the technical capabilities related to sterile manufacturing. After a thorough analysis, a Team of people developed a program consisting of approximately 40 computer-based courses to be delivered to professionals joining the flow teams and process teams from school or from different roles. The project was accomplished leveraging more than 30 subject matter experts in various disciplines, and an external contractors specialized in computer-based courses. These courses have been integrated with movies of production environment, animations, pictures, etc… Topics covered include all Sterility Assurance topics (both for standard clean rooms + RABS +Isolators), Process (Formulation, Sterile Filtration, Filling, Inspection), Lab methods (Chemical, biological, physical), Validation (Process, Cleaning, Sterilization), Control strategy, Material Science, Forensic, etc… All courses are freely available to Lilly employees and are included in the Lilly Education and Training electronic system
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