アガサ Company Overview

In recent years, driven by advancements in AI/ML utilization and strengthened regulations, the digital transformation in pharmaceutical manufacturing has become urgent. This webinar will systematically explain the fundamentals to implementation of digital twins, a topic of increasing attention, for enhancing manufacturing processes. We will discuss how to utilize related technologies such as MPC and soft sensors, as well as European case studies and the latest trends, specifically organizing "where to start" and "how to apply it to your company." Additionally, we will address common challenges faced during the implementation consideration phase and key points for promotion, providing insights that can be applied in practice. This content is ideal for those in manufacturing, quality, and DX promotion departments. As seating is limited, please register early. 【Program】 Part 1: 14:05–15:00 "Methodology for Applying Digital Twins to Pharmaceutical Manufacturing Processes" Koji Tanaka, Kelber Japan Co., Ltd. Part 2: 15:00–15:05 "Introduction to Agatha" Agatha Co., Ltd. Part 3: 15:05–15:20 "Q&A Session" *Questions will be collected during the webinar.

In recent years, as the importance of quality issues and inspection responses has increased in the pharmaceutical industry, there has also been a growing interest in the key points of GMP audits and the approach to addressing them. This content introduces an on-demand presentation that explains the fundamental concepts of audits and the perspectives for verification, based on the GMP audit manual (draft) from a previously well-received webinar. ■Content - Basic concepts of GMP audits - An example of points verified during audits - Considerations for verifying the quality assurance system - Evaluation of audit results and approaches for improvement *This content is based on information available at the time of distribution.

We have published the 6th installment of our partner, CAC Corporation's contributed column series titled "Points Customers Tend to Overlook and Unexpected Challenges." The theme of the 6th installment is "Maintaining CSV and Continuous Improvement - To Keep a Validated State." ■ Overview The most important aspect of CSV is not the moment of system implementation. The essence lies in continuously maintaining the "validated state" while responding to changes in business, regulations, and technology over the years following system operation. This column focuses on the operational phase and explains the key strategies and practices for "maintaining" CSV. ■ Key Points - The concept of impact assessment and re-validation in change management - Risk management to avoid underestimating configuration changes - Preventing "logical degradation" through self-inspection and regular reviews - Points for operation and education to prevent the formalization of SOPs - The direction of efficiency and evolution of CSV in the CSA era ■ Column Agenda 1. The importance of change management 2. The importance of self-inspection and regular reviews 3. Compliance with SOPs and prevention of formalization 4. Continuous improvement of CSV 5. Summary: CSV is a "journey"