モレキュラーデバイスジャパン 東京本社 Official site

Free Seminar: Basic Requirements for CSV and Data Integrity and Inspection Response

モレキュラーデバイスジャパン 東京本社

Basic Knowledge of CSV, Roles of Users and Suppliers, Category Classification, Recent Developments in DI Guidance, Points to Consider in Contracted Operations, Considerations for Managing and Handling Electronic Data, Key Points for CSV and DI Inspections by Regulatory Authorities, Special Seminar with Clear Explanations Based on Extensive Experience!! ◆Instructor Kenichi Ogiwara, Representative of C-Cast Co., Ltd. Currently active after working at Yokogawa Electric Corporation and Nomura Research Institute. ◆Target Audience Individuals involved in CSV and Data Integrity at pharmaceutical companies, medical device manufacturers, suppliers, etc. ◆Prerequisites No specific prior knowledge required. ◆Knowledge to be Acquired 1) Basic knowledge of CSV 2) Role division between users and suppliers in CSV 3) Correct thinking about category classification 4) Recent status of data integrity guidance 5) Japanese authorities' perspective on data integrity 6) Points to consider in contracted operations (labs and manufacturing) 7) Considerations for managing and handling electronic data 8) Key points for inspections of CSV and data integrity by regulatory authorities.