Seminar Announcement: "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from the Biopharmaceutical Manufacturing Field" (October 2024)

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.

• Other electronic measuring instruments

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.

• Analytical Equipment and Devices

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.

• Other measurement, recording and measuring instruments

[Speaker] Kazuharu Yamamoto Partner Expert, Roland Berger Co., Ltd. [Key Lecture Content] In the automotive industry, the topic of EVs is ever-present. The advancement and promotion of EVs is a significant goal for achieving carbon neutrality (CN). On the other hand, the realization of CN and the progress of EVs are inseparable topics related to the realization of a circular economy (CE). In this lecture, I will present an overview of CE and CN, discuss the mechanisms of CE progressing in Europe, and the reverse supply chain, while also addressing the expansion of EVs and charging infrastructure from a consumer perspective. [Lecture Items] 1. Overview of CE and CN in the automotive industry and EVs 2. Mechanisms for achieving CE in Europe 3. Expansion of EVs and charging infrastructure (Characteristics of Japan within the global context) 4. Q&A / Business card exchange

[Speaker] Mitsune Shirasawa, Partner Attorney at TMI General Legal Practice [Key Lecture Content] The regulations that must be complied with when implementing payment businesses are defined by various laws, and it is common for the applicable laws to change due to subtle differences in the schemes adopted. Therefore, when building a business related to payments, it is essential to have not only an understanding of individual laws but also a cross-sectional understanding of how these laws interact with each other. Additionally, recent developments such as the categorization of money transfer businesses, the introduction of regulations regarding stablecoins, the clarification of payment collection services, and the emergence of new schemes like BNPL (Buy Now Pay Later) and BPSP (Business Payment Service Provider) have led to significant advancements and complexities in payment-related businesses. Thus, this seminar will provide a comprehensive explanation of the current regulations surrounding payment businesses and their practical responses. [Lecture Topics] 1. The environment surrounding payment legislation 2. Keywords related to payment and regulatory compliance 3. The overall picture of laws and regulations surrounding payments 4. Points to consider when building a business / When to consider potential conflicts with financial regulations 5. How to obtain permits and licenses related to payments 6. Q&A / Business card exchange

[Speaker] Yusuke Saiki Executive Officer, Consulting Division Head of Strategy & Innovation Unit Ignition Point Inc. [Key Lecture Content] As marketing becomes increasingly complex, the disconnect in "information, experience, and perspectives" between organizations, departments, and customer touchpoints has become a significant barrier to business growth. The key to overcoming this "era of division" lies in "co-creative marketing," which merges AI's analytical power with human creativity and empathy. In this lecture, we will introduce strategic approaches and specific actions based on practical examples of co-creative marketing that Ignition Point has supported. [Lecture Items] 1. The irreversible changes that AI brings to the business environment and the emergence of new challenges in marketing 2. Why is business growth being hindered in the digital age? 3. What is the key to overcoming division: "Co-creative Marketing Strategy"? 4. Based on Ignition Point's examples, the practice and strategic approach of "Co-creative Marketing Strategy" 5. Three steps to start implementing "Co-creative Marketing Strategy" from tomorrow 6. Q&A / Business card exchange

[Speaker] Yusuke Saiki Executive Officer, Consulting Division Head of Strategy & Innovation Unit, Ignition Point Inc. [Key Lecture Content] This presentation is aimed at solution sales professionals who feel the limitations of traditional, person-dependent sales methods. We will provide specific thinking methods, strategies, tools, and practical action plans to strategically leverage AI and shift from "passive problem-solving" to "active opportunity creation." Participants will gain insights and techniques to build a new sales style suitable for the AI era within their own sales organizations. [Lecture Items] 1. Why are changes occurring now in the sales environments of other companies? 2. The required transformation of sales styles 3. How to utilize generative AI to transform into proactive solution sales 4. Transitioning from problem-solving solution sales to problem-posing solution sales 5. Introduction and demonstration of practical tools and skills that can be used from today 6. Q&A / Business card exchange

[Key Lecture Content] 1. Overview of the grid-scale battery business and actual operations Kenji Eda, President of RAUL Co., Ltd. Director of the Energy Information Center 1. What is the grid-scale battery business? 2. Business revenue structure / various markets / subsidies, etc. 3. Flow from consideration of introduction to start of operation / points to note 4. Case studies of grid-scale batteries / introduction of actual cases 2. Business players in the grid-scale battery sector / specific company examples / Q&A for entry Hironobu Takeuchi, Manager of the Grid-Scale Battery Business Division at RAUL Co., Ltd. 1. Introduction to the classification of business players and their roles 2. Specific company examples for each player 3. Frequently asked questions and answers from entering companies 4. Q&A session / business card exchange