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  4. [On-Demand Streaming] "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites"
SEMINAR_EVENT
  • Nov 29, 2024
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Nov 29, 2024

[On-Demand Streaming] "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites"

ハックジャパン ハックジャパン
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.
Date and time Friday, Nov 29, 2024 ~ Wednesday, Dec 11, 2024
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QbD1200+_mini_2web.jpg

Lab TOC meter QbD1200+

Data integrity compliance for pharmaceuticals, public bathhouse law, water quality testing for drinking water, tap water, and well water, cleaning and water quality management, TOC testing of plastic components.

The Hach QbD1200+ is a laboratory TOC analyzer that supports a wide range of TOC measurements, including ultrapure water and pharmaceutical water in the pharmaceutical industry, cleaning validation, TOC testing of plastic materials/plastic packaging systems, and compliance with regulations concerning tap water, drinking water, well water, and water quality management in cosmetics manufacturing, as well as cleaning line management. Specifically, it complies with various guidelines and implementation requirements, such as 3rd party conformity, PIC/S GMP, 21 CFR Part 11, and data integrity, making it ideal for regulatory compliance. Additionally, even for non-regulatory matters, it serves as a benchmark for internal standards (SOP) related to quality management within the company, allowing for the regular management and accurate, efficient recording of TOC values. Its compact design and intuitive operation have also received positive feedback.

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[Overseas Case] Total Organic Carbon (TOC) Analyzer for Laboratory QbD1200+

Significantly improved inspection efficiency! A case that ensured the consistency and traceability of standard samples!

We would like to introduce a case where a pharmaceutical industry inspection equipment manufacturer in Sichuan Province has implemented our lab TOC analyzer "QbD1200+". The company conducted high-precision testing and data calibration for each batch of various TOC standard samples developed in-house. Using the custom calibration curve function of this product, they created a calibration curve that met the performance indicator of a linear correlation R2 ≧ 0.999 within the range of 0 to 2000 ppb. Additionally, regarding accuracy and reproducibility, it also met the performance specifications for low-concentration TOC samples. 【Case Overview】 ■ Background - A highly advanced contamination control strategy is required to meet the performance levels demanded by the pharmaceutical industry. - Capable of rapid, efficient, accurate, and stable TOC measurements. - Assurance of high-quality standard sample production. *For more detailed information, please refer to the related links. For further inquiries, feel free to contact us.

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

Introducing a case study of the implementation of TOC (Theory of Constraints) that achieved a reduction in labor hours and costs for examiners!

We would like to introduce a case study of Company A, a pharmaceutical factory that has implemented the lab-type TOC analyzer "QbD1200." The company conducts TOC testing at 12 use points from purified water and water for injection each time, but occasionally the TOC values would be negative or show results below the usual threshold of 10 ppb. After the implementation, they reported, "We are getting stable results below 20 ppb, and we have established a system that allows direct data transfer from the device without going through a PC." [Case Overview] ■ Benefits of Implementation - Stable TOC measurement values of 10 to 20 ppb have been confirmed. - The operation screen is easy to understand, resembling a tablet interface. - There is an automated testing procedure that covers everything from daily inspections to TOC measurements. - Measures such as automatic carryover prevention have reduced the workload for testers. - It is beneficial to receive direct support and information from the manufacturer, Hack. *For more details, please refer to the PDF document or feel free to contact us.

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Lab TOC Meter QbD1200+ Catalog (Pharmaceuticals, Purified Water, Cosmetics, etc.) | Hack Japan

Lab TOC Meter QbD1200+ Catalog (Pharmaceuticals, Purified Water, Cosmetics, etc.) | Hack Japan

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

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

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Testing, Analysis and Measurement
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[Seminar] Maximizing Team Strength through Shared Leadership

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[Speaker] Jun Ishikawa, Professor at the Graduate School of Business Administration, Rikkyo University, and Vice President of Rikkyo University [Key Lecture Content] This lecture will provide a clear explanation of the most effective leadership in the VUCA era, focusing on shared leadership based on the latest research. Specifically, it will discuss how everyone can exhibit effective leadership to improve workplace and team outcomes, and how anyone can develop effective leadership skills through training. Additionally, it will explain what is necessary to foster shared leadership in workplaces and teams from both individual and organizational perspectives. To continue achieving results in the VUCA era, let’s challenge traditional views of leadership and explore new leadership concepts. [Lecture Items] 1. Characteristics of the VUCA Era 2. What is Shared Leadership? 3. Effects of Shared Leadership 4. Effectiveness of Personal Leadership Theories 5. How to Foster Shared Leadership in Workplaces and Teams 6. Q&A *This seminar will be held via Zoom meeting.*

Feb 14, 2026

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[Seminar] North America DISTRIBUTECH 2026 Report: The Frontline of Smart Meters (AMI) and DER Utilization

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[Speaker] PwC Advisory LLC Senior Manager Toshiya Nakamura [Key Lecture Content] The expected roles of smart meters (AMI) and DER (Distributed Energy Resources) in power systems are increasing both domestically and internationally. The DISTRIBUTECH conference, one of North America's largest exhibitions and conferences for transmission, distribution, and energy-related technologies, will be held in early February 2026 in San Diego, North America. Numerous power companies and manufacturers introduced the latest trends regarding the next-generation smart meter systems AMI 2.0 and the utilization of DER. In this lecture, I will share the latest trends in the utilization of smart meters and DER in the decentralization of power systems gained through participation in DISTRIBUTECH. [Lecture Items] 1. Overview of DISTRIBUTECH 2. Latest trends in AMI 2.0 3. Latest trends in DER utilization 4. Considerations for the utilization of smart meters and DER 5. Q&A / Business card exchange

Feb 14, 2026

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[Seminar] Tesla's Medium to Long-Term Business Strategy

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[Speaker] Mr. Li Qiangfu, Senior Researcher, Planning and Research Department, Fourin Inc. [Lecture Topics] 1. Tesla Master Plan: Progress of Existing and New Businesses 2. Strategy as a Technology Trendsetter 3. Initiatives in Purchasing and Supply Chain 4. Efforts as an IT Service Platform Provider 5. Competition with Chinese Companies and Strategies to Differentiate 6. Q&A / Business Card Exchange

Feb 14, 2026

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P-CAM R

Notice of Participation in the 55th ASM OSAKA 2026

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We will be exhibiting at the "55th ASM OSAKA 2026" held at Intex Osaka. At this exhibition, you can see demonstrations of our layered automatic cutting machine (NC cutting machine) <P-CAM R>, which offers improved cutting accuracy and productivity with excellent cost performance, as well as the automatic fabric spreading machine <P-SPR2L>, which can spread fabric in an optimal state for cutting. We will also introduce our apparel CAD (design CAD) software <APEXFiz PGM>, which achieves excellent efficiency and operability through enhanced integration with cutting machines, from pattern design to size development, and our design software <APEXFiz Design>, which allows for everything from planning and design to color consideration, realistic fabric simulation, and 3D virtual sampling of products. Booth No.: 1 Exhibition Contents: P-CAM R P-SPR2L P-CAM120C SWG091N2 APEXFiz PGM SDS KnitPaint-Online APEXFiz Design Cutting Samples Knit Samples <Contact Information> Cutting Solutions Division, Moriuchi, TEL: 073-474-8239

Feb 13, 2026

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February 25, 2026 (Wednesday) 13:30 - "Teach Me About Power ICs: Basics of Lithium-Ion Batteries and Protection ICs"

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The goal is to understand the roles and functions of lithium-ion batteries and protection ICs, learn the basics of lithium-ion batteries and protection ICs, and provide fundamental information that can assist in the selection of protection ICs and subsequent circuit design. ● Target Participants - New employees and young designers at companies developing products related to lithium-ion batteries - Those who want to revisit the study of lithium-ion protection ICs - Those who are about to engage in circuit design related to lithium-ion batteries ● Agenda 1. What is a lithium-ion battery? 2. Types of lithium-ion secondary batteries (LIB) 3. Major manufacturers of LIB (Cell Maker) 4. LIB Supply Chain 5. Why is protection for LIB necessary? 6. Methods of LIB protection 7. Basic operation of protection circuits 8. Product lineup of Nisshinbo Micro Devices 9. Chip cross-section (process structure) 10. Rules for product names 11. Trends and considerations for secondary batteries (to be added in 2026) 12. Q&A

Feb 13, 2026

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