[Brochure] "Education Designer"

With the amendments to laws and regulations such as the "Pharmaceutical and Medical Device Act," "GMP Ordinance," and "QMS Ordinance," the importance of "educational management" is gaining attention. How are you implementing internal education within your company? We want to conduct education for thorough understanding, but we are receiving more inquiries like, "How can we efficiently implement education?" This time, we will hold a seminar on educational management using our educational management system, "Education Designer." The system allows for the entire process from education implementation to confirmation tests, as well as the creation of skill maps, to be systematized and recorded as audit trails. On the day of the seminar, we will introduce the background requiring internal education and the challenges faced in internal education, along with a demonstration using actual screens. This is a must-attend for companies facing issues such as, "It's difficult to grasp the status of education implementation," and "Managing skills after education implementation is challenging." <Seminar Content> - Demonstration using Education Designer - Importance of educational management <Seminar Target Audience> - Personnel considering the systematization of internal education We look forward to your application!

Thank you very much for your continued support of our seminars. The topic of this seminar is "GMP Regulations," which are fundamental and essential rules in pharmaceutical manufacturing. It has been two years since the revisions were made in April 2021. I believe many of you have already completed your compliance and are now engaged in pharmaceutical manufacturing under the new GMP regulations. In this seminar, I would like to present the "GMP Regulations" in a way that is suitable for beginners. For those who have just started working in this field this spring, or for those whose clients are in pharmaceutical manufacturing and are looking to learn the basics, I hope this will be of some reference, so please join us. *This seminar is aimed at beginners. Please note that the content may be simplistic for those who are already engaged in GMP operations. <Seminar Content> - What are GMP Regulations? - Key points to understand - Background of the revisions and key changes - Improvements in GMP operations through digitalization <Target Audience> - Those who have just started working in GMP this year - Those whose clients are in the pharmaceutical manufacturing industry - Those who wish to deepen their understanding of GMP regulations If you are interested, please feel free to join our free seminar.

In the pharmaceutical manufacturing industry, conducting "evaluations" when using computer systems for business operations is now regarded as an essential and natural practice. Amid this, we have been receiving more inquiries from our partner companies involved in "pharmaceutical manufacturing," asking, "We were told to implement CSV compliance, but what should we do?" This time, although we do not manufacture pharmaceuticals ourselves, we will provide a simple explanation of the basic concepts and methods of CSV compliance for those who produce related raw materials and ingredients. We hope you take this opportunity to learn the "basics of CSV compliance" and use it as a reference for smoothly responding to requests from your clients. <Seminar Content> - What is CSV? - Basic concepts for compliance - Methods and points to note for compliance - Frequently asked questions <Seminar Target Audience> - Quality department personnel from companies that have pharmaceutical manufacturing as clients - Those who are encountering CSV compliance for the first time * The content will focus on basic information. Please note that it may not be sufficient for experienced individuals.

We will be exhibiting at "Medtec Japan," which will be held at Tokyo Big Sight from April 19 (Wednesday) to April 21 (Friday) this year. On that day, we will focus on our document management system "Document Designer for GxP," offering specialized proposals for document management, including options for "Issuing and Managing Manufacturing Records." We will also introduce "Quality Designer for GxP," which enables management of quality events such as CAPA management and non-conformance management, as well as "Training Designer," which provides comprehensive support for the implementation and management of training. We understand you are very busy, but we look forward to your visit.