Organizer: Dandelion (Suzhou) medical service platform
International Fermentation Exhibition, Instrument Biochemistry Exhibition
Organizer: Suzhou Leberman Pharmaceutical Technology Co., Ltd
Co organizer: Beijing Jinruibo Information Consulting Co., Ltd
Jiangsu Aisulai Biotechnology Co., Ltd
Meeting arrangements
Time: 09:30-16:00, March 5
Location: On site meeting room of Shandong International Convention and Exhibition Center Hall 2
09:30-10:30 Management of laboratory sample inspection process
10:45-12:00 Analysis of OOS investigation strategy
13:00-14:00 Microbiological identification and database building strategy of pharmaceutical enterprises
14:15-15:15 OOS/OOT/OOE result investigation and case analysis
15:15-16:50 Typical cases of insufficient investigation in official/unofficial inspection and analysis summary
Lecturer introduction:
Xia Zhenhua: Senior engineer, senior economist, licensed pharmacist, chief pharmacist, once served as factory director, general manager, R&D quality director, etc. in two major listed pharmaceutical companies and state-owned pharmaceutical enterprises. Graduated from China Pharmaceutical University majoring in pharmaceutical analysis, he has been engaged in quality control and quality management of APIs, capsules, tablets, granules, injections, etc. for nearly 40 years, and has published more than 20 papers on quality control and quality management (of which the analytical methods in three papers were adopted by the current USP, European Pharmacopoeia and Chinese Pharmacopoeia), He has organized, guided and passed more than 10 inspections by FDA, EU, Germany, Japan, etc. He has a good understanding and attainments in quality management and quality control, and has granted a patent.
Zhang Lei: Jinruibo Consulting General Manager and GMP compliance expert. Mainly engaged in domestic, European and American international GMP compliance, third-party audit and other work, presided over or participated in the international GMP certification consulting services of several pharmaceutical enterprises, in the pharmaceutical compliance internationalization planning, information system compliance, biological medicine/chemical medicine international GMP compliance, overseas enterprises' Chinese access GMP compliance, data integrity assessment and rectification, plant facilities and equipment compliance He has rich experience in the construction and improvement of quality system, the construction of quality culture, and the merger and acquisition compliance DD of pharmaceutical enterprises.
Xiong Xiaogang: Jin Ruibo Consulting Partner and GMP Consulting Director. He has successively engaged in QC and quality management in Korea and the United States, Yangtze River, East Sunshine and Yabao, and has participated in 20+FDA/EU/WHO/TGA/PIC/S GMP inspection and overseas inspection projects in China. He is good at QC laboratory management and compliance, quality management, deviation/OOS/abnormality investigation and rectification, complex problem discussion and solution, GMP professional training and training, and GMP professional translation.
Teacher Ning: 19 years of work experience in foreign-funded pharmaceutical enterprises, including Korean enterprises, American enterprises, German enterprises and French enterprises, has been working on microbiological control, and is the head of microbiological laboratory. Be familiar with domestic and foreign laws and regulations, have rich theoretical knowledge and practical experience in microbial risk assessment, detection method development and validation, microbial identification and database building, and lead the team to complete domestic and foreign audits for many times. Professional skills training lecturer of Suzhou Park Human Resources and Social Security Bureau, who has given lectures to pharmaceutical enterprises for many times, and is good at sharing with the actual situation.
Exhibition introduction
The 12th 2024 International Biofermentation Products and Technical Equipment Exhibition (Jinan), sponsored by China Biofermentation Industry Association and co organized by Shandong Biofermentation Industry Association, and organized by Shanghai Xinshi Exhibition Services Co., Ltd., will be grandly opened in Shandong International Convention and Exhibition Center on March 5-7. This exhibition covers 30000 square meters, with more than 500 exhibitors, and exhibits covering biological fermentation All kinds of new products, new technologies, new equipment and new processes required for the production and processing of biotechnology, medicine, biopharmaceuticals, bioengineering, cell engineering, genetic engineering, biopharmaceuticals, food, beer and beverage, biochemistry, biological feed, etc., create a whole industry chain integrating "exhibition, commerce, learning and exchange", It is committed to one-stop solutions for intelligent manufacturing in biotechnology industry.
(The above content is released by Shanghai Xinshiyule)
