[Seminar] Key Points of Quality Control for Biopharmaceuticals and Antibody Drugs

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.

basic information

【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.