In order to strengthen the laboratory's full life cycle compliance management capabilities for drugs and medical devices and facilitate the high-quality transformation of scientific research results, the Regulatory Science Lecture (Phase 1) was successfully held in the laboratory on March 12. This lecture focused on the core themes of GxP quality management system establishment and risk management and control. Personnel from various scientific research teams, operating departments, and units actively participated in learning and exchanging cutting-edge knowledge and practical points on compliance management.

The event invited Mr. Wang Shuhong, a senior industry expert with 25 years of practical experience in GxP quality management and deep experience in international pharmaceutical companies such as Novartis and Bayer, to give a lecture. With the core idea of ​​"beginning with the end in mind - verification as the ruler and system as the basis", Mr. Wang gave professional explanations on key contents such as the judgment standards for on-site registration inspections, the construction of quality management systems (QMS) under the Quality by Design (QbD) concept, and the analysis of GMP critical quality defect items. At the same time, he also provided detailed answers to hot and difficult issues in the industry such as on-site registration inspections of AI-assisted diagnostic software and construction of compliance training databases. The teaching content is closely combined with industry regulatory requirements and practical cases, and includes both systematic theoretical review and targeted practical guidance, bringing professional and practical knowledge sharing to on-site participants.

After the sharing, the on-site participants conducted in-depth exchanges and discussions with Mr. Wang on issues such as compliance control difficulties and risk assessment points in R&D and production based on their own work realities. Mr. Wang answered each question in detail. The on-site interactive atmosphere was strong, and all participants said they had gained a lot. It has important guiding significance for standardizing compliance management and avoiding quality risks in subsequent work.

At the event site, a collection of opinions for the next lecture was also carried out simultaneously, and suggestions from participants on course themes, content design, etc. were widely collected. In the future, the Jinfeng Laboratory Regulatory Science Lecture Hall will continue to focus on the actual needs of laboratory scientific research and operation management, regularly plan and carry out a series of special sharing activities, build a professional learning and exchange platform, continuously improve the compliance management literacy and practical ability of all employees, and lay a solid foundation for compliance management for the high-quality development of the laboratory.