Detailed explanations of specific trouble countermeasures! You will gain practical knowledge directly applicable to your work.
We will hold a WEB seminar titled "Key Points and Specific Troubleshooting for Quality Control of Biopharmaceuticals and Antibody Drugs." Quickly resolve the "manufacturing site issues" of biopharmaceuticals and antibody drugs. You can acquire practical know-how to control quality risks and skillfully utilize GMP and QMS, from preventing troubles in the manufacturing process to applying advanced ICH guidelines, all in one day. 【Seminar Overview (Partial)】 ■ Date: September 1, 2025 (Monday) 10:00 AM - 4:00 PM ■ Venue: Online only (Zoom system) ■ Participation Fee (including tax): 49,500 yen per person ■ Course Materials: PDF materials (included in the participation fee) *For more details, please download the PDF or feel free to contact us.
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【Acquired Knowledge (Part of)】 ■Basic quality risks specific to biopharmaceuticals and antibodies and their control ■Quality design and trouble prevention measures in manufacturing processes (upstream, downstream, formulation) ■Practical quality management by modality, such as antibody-drug conjugates (ADCs) ■Institutional differences and practical distinctions between GMP/GCTP/QMS ■Specific points for approval applications (CTD) and change management (ICH Q12) ■Practical know-how for QTA, audits, and inspection responses in contract manufacturing *For more details, please download the PDF or feel free to contact us.
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For more details, please download the PDF or feel free to contact us.
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TH Planning Co., Ltd. is a company that conducts technical seminars, dispatches instructors for training, and provides technical consulting. We aim to contribute to the development of manufacturing and value creation by creating educational opportunities that provide specialized knowledge and know-how in technology and by becoming a hub that connects technologies. Please feel free to contact us when you need our services.