Recommended for: Those who want to know specific measures to respond to administrative inquiries / Those who want to streamline audit response operations.
In recent years, audits by governments and various organizations in the life sciences industry have become increasingly stringent, leading to a rise in the number of identified issues. This trend can be attributed to several factors, including the elevation of standards required across the industry and the increased visibility of deficiencies and problems due to the proliferation of digital technologies. In this webinar, we will interpret the latest trends in the life sciences industry and clearly explain the measures to address the regulations and standards that are particularly important to keep in mind. In the latter half, we will provide a detailed introduction to the quality management system "MasterControl," which has been implemented in over 1,000 companies globally and many major life sciences companies in Japan. We will share specific effects of digitized quality assurance business processes and tips that can help solve your company's challenges. *This content is similar to that conducted in June 2025. Event Overview Date and Time: September 4, 2025 (Thursday) 14:00 - 14:35 Venue: Online Register here → https://www.fujifilm.com/fbds/news/20250805
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basic information
【Support for Optimal Design and Accurate Execution of Quality Assurance Operations】 By visualizing and organizing complex business processes, we can stably operate the PDCA cycle of quality management. Our solutions leverage extensive experience in the medical device industry to support the design of optimal business processes, and by utilizing MasterControl to digitize processes, we strongly support smooth operations. This enables the accurate execution of daily tasks such as document version control, change management, planning and management of training, and management of quality events like complaints without any omissions. 【Thorough Preparation for Audits and Compliance with Abundant Best Practices】 Through our extensive implementation experience in the life sciences industry, we have accumulated numerous best practices. We provide a variety of templates and frameworks that comply with domestic regulations and ISO standards, as well as international standards such as FDA, ICH, and IMDRF, alleviating concerns regarding inspections, audits, and compliance.
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Adopted by the FDA (U.S. Food and Drug Administration)! This solution is implemented by over 1,000 other companies.
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Pacific Business Consulting has been supporting the promotion of DX by utilizing technology for group affiliates and many customers. We provide the know-how cultivated through that experience to our customers through various solutions and services.
