アガサ Company Profile

In quality management that includes GMP, it is important for education and training to function continuously as a system that ensures quality, rather than being a one-time event. In this webinar, we will organize the objectives and ideal state of education and training, and explain the concept of preventing recurrence through common failure examples that occur on-site. Additionally, we will introduce practical points for education and training management using job descriptions and skill maps, as well as an operational image using Aves-TMS. 【Program】 Part 1: 14:05–15:00 "Education and Training Management Utilizing Job Descriptions and Skill Maps" Daichi Takahashi, Director, Pharma Planning Co., Ltd. Part 2: 15:00–15:10 "Introduction to Agatha Solutions" Quality Group, Sales & Marketing Department, Agatha Co., Ltd. Part 3: 15:10–15:30 "Aves-TMS Demo Presentation" BIO-TREND BIOPRODUCTS Co., Ltd. Part 4: 15:30–15:40 "Q&A Session" *Questions will be collected during the webinar.

For companies managing clinical trial documents on paper, you may be facing challenges such as spending a lot of time searching for and verifying documents, or having to gather, file, and check for missing documents before audits and inspections. In this webinar, we will outline the unique challenges and future risks associated with paper management and introduce how companies operating with paper management can "gradually and effortlessly" improve by utilizing Agatha eTMF. We will provide feedback from companies currently using the system, specific implementation effects based on user surveys, and a demonstration to give you a clear image of on-site operations. 【Program】 Part 1: 14:00 - 14:20 "Implementation Effects and Future Developments of Agatha as Seen from the eTMF User Survey" Part 2: 14:20 - 14:40 "Introduction to Agatha eTMF Solutions and Demonstration" Agatha Inc. Sales & Marketing Department Life Sciences Group Part 3: 14:40 - 14:50 "Q&A Session" *We plan to collect questions during the webinar.

We are pleased to announce the launch of a new column series titled "Points Often Overlooked by Customers and Unexpected Challenges," brought to you by our partner, CAC Corporation. The first installment is themed "Reconsidering the Basics of CSV - What is the Purpose of CSV?" and it explains the essence of Computerized System Validation (CSV) and the issues that are often overlooked on the ground. ■ Key Points - Transforming CSV from a "requirement" to a "strategic investment" - What risks arise from a lack of purpose-driven responses? - Efficient validation through a risk-based approach - Latest regulatory trends considering data integrity and AI implementation ■ Column Agenda 1. Reunderstanding the Principles of CSV: Investing in Future Reliability Assurance 2. The Importance of Purpose Awareness: Preventing Formalism 3. Clarifying the Scope of Validation: Allocating Resources for Necessary Verification 4. Latest Regulatory Trends and Their Impact on CSV: Considering Collaboration with Experts 5. Conclusion - Positioning CSV as a "Strategic Investment"