[Case Study] Pharmaceutical Factory Lab-type TOC Meter 'QbD1200'

Hack Japan held a seminar (in-person) on October 18 (Friday). In response to requests from those who could not attend this seminar, we will be offering on-demand streaming of three sessions of lectures and presentations for a limited time. This seminar is aimed at personnel involved in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry. Applications from competing companies will not be accepted. Thank you for your understanding.

Hack Japan held a seminar (in-person) on October 18 (Friday). In response to requests from those who could not attend this seminar, we will be offering three sessions of lectures and presentations on a limited-time on-demand basis. "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites" ■ Distribution Deadline: December 11, 2024 (Wednesday) ■ Content: ◎ Lecture 1 (Viewing Time: Approximately 1 hour) "Efforts in Cleaning Validation Utilizing TOC" Katsuharu Miyajima, Palmex Therapeutics Co., Ltd. ◎ Lecture 2 (Viewing Time: Approximately 45 minutes) "Current Status and Challenges of Cleaning Validation in Biopharmaceutical Manufacturing" Shinichi Fujimura, Takara Bio Inc. ◎ Presentation (Viewing Time: Approximately 20 minutes) "Lab TOC Meter QbD1200 + - Regarding High-Quality Data Integrity Compliance" Masatsugu Okada, Hack Japan Co., Ltd. ■ Target Audience: Personnel in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry. *Please note that applications from other companies in the same industry will not be accepted. Thank you for your understanding.

**Seminar Held with Mr. Miyajima from Palm X Therapeutics and Mr. Fujimura from Takara Bio** Our company will hold a seminar on October 18 (Friday) in Tokyo for professionals involved in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry. ■ Title: "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites" ■ Date and Time: October 18, 2024 (Friday) 13:30 - 17:00, Doors Open: 13:00 ■ Venue: Waim Conference Room Takadanobaba 4B (4th Floor, TD Building, 1-29-9 Takadanobaba, Shinjuku-ku, Tokyo) ■ Capacity: 50 people (planned) ■ Application Deadline: October 7, 2024 (Monday) *Registration will close if capacity is reached before the deadline. ■ Participation Fee: Free ■ Target Audience: Professionals involved in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry ■ Organized by: Hack Japan Co., Ltd. (formerly Hack Ultra)

In the guidance on process validation (PV) announced by the FDA in 2011, PV is classified into three stages: Stage 1, process design; Stage 2, verification of the functionality of the designed process in the actual manufacturing site; and Stage 3, verification of functionality according to design during the production phase after product launch. The importance of process validation throughout the entire product lifecycle is increasing. This seminar will focus on the latest trends in cleaning validation in Stage 3, which is emphasized as a measure against cross-contamination, particularly with the increase in many pharmaceuticals and highly active pharmaceuticals manufactured on shared lines. We will also highlight the usefulness of Total Organic Carbon (TOC) analysis methods and present practical examples from biopharmaceutical manufacturing sites. Additionally, in the latter part of the seminar, there will be time for discussion led by the speakers. If you have any topics or questions you would like to be addressed, please include them in the application form.