[Seminar] Chemical and Safety Evaluation of Pharmaceutical Impurities and Management Points
Strengthening quality assurance and safety evaluation! A thorough explanation of practical points for chemical and safety assessments.
We will hold a seminar titled "Chemical and Safety Evaluation and Management Points of Pharmaceutical Impurities (Organic Impurities, Inorganic Impurities, Residual Solvents) - Including ICH Q3A, Q3B, Q3C, Q3D, and ICH M7 Guidelines." Impurity management, which affects the quality and safety of pharmaceuticals. This seminar will comprehensively cover organic impurities, inorganic impurities, residual solvents, as well as elemental impurities from ICH Q3D and mutagenic impurities from ICH M7, providing thorough explanations of practical points for chemical and safety evaluations. Additionally, we will specifically introduce regulatory trends, risk assessments, and points to consider when writing CTD, allowing participants to acquire knowledge directly applicable to the practices of QA, QC, CMC, and manufacturing departments. We sincerely look forward to your participation. 【Seminar Overview (Partial)】 ■ Date: October 22, 2025 (Wednesday) 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) *Please apply early as the registration will close once the capacity is reached.
basic information
【Acquired Knowledge】 ■Chemical and safety evaluation of pharmaceutical impurities (organic impurities, inorganic impurities, residual solvents) ■Understanding impurities and impurity management in pharmaceutical raw materials (ICH Q3A, Q3C) ■Learning about analytical methods for impurities and method validation ■Knowledge of impurities that should be set as standards, and the determination of impurity structures and safety ■Learning about the permissible daily exposure (PDE) for residual solvents ■Basic knowledge of ICH M7 and ICH Q3D, and points to consider when writing CTD ■Selection/validity of starting materials for active pharmaceutical ingredients in ICH Q11, and setting of CQA and CPP ■Risk assessment of nitrosamines *Please apply early as the deadline will be closed once the capacity is reached.
Price information
■Tuition fee (including tax): 49,500 yen per person
Price range
P2
Delivery Time
OTHER
Applications/Examples of results
Please apply as soon as possible, as the application will close once the capacity is reached.
