Shanghai Fermentation Exhibition Conference Preview: Difficult Analysis Seminar on the Implementation of Equipment Engineering for Pharmaceutical Project Facilities

First, the background of the Forum With the implementation of drug GMP, the layout of regional industrial policies, scientific and technological progress and the needs of drug development and transformation, how to implement new construction and transformation projects has become a challenge for pharmaceutical companies.
How to introduce quality from the concept of design in new projects, based on risk and science of project planning, design, construction, certification, etc., to ensure that new projects are efficient and compliant to meet the needs of long-term operation;
In order to help enterprises solve the difficulties and problems encountered in the actual work, so that pharmaceutical enterprises as soon as possible into the implementation phase of GMP, better for new projects, legacy / transformation or relocation of the difficulties of training and discussion, to solve the problems encountered in project planning and implementation, enhance the compliance of GMP regulations, reduce the cost of transformation.
At the request of the vast number of enterprises, the Pharmaceutical Technology Committee of the China Medical Education Association will jointly organize a seminar on "Difficult Analysis of the Implementation of Equipment Engineering for Pharmaceutical Project Facilities" in cooperation with the Organizing Committee of the International Biofermentation Exhibition, and visit the 2020 Shanghai International Biofermentation Technology and Equipment Exhibition and the Theme Exhibition of Biopharmaceutical and Technical Equipment, inviting all units to actively select personnel to participate.
the following are heeded: II, scope of presentation: 1, antibodies, vaccines, bioinfoss, biologics, biomanstructures, biotechnology, cell biology, clinical trials, new drug research and development, genomics/genetics, intellectual property, nanotechnology, biotechnology Equipment, etc.: 2, fermentation tanks, glycation tanks, storage tanks, evaporation equipment, crystallization equipment, cell culture systems (instruments), cell reactors, bioreactive devices, purification distillation equipment, cell culturers, shakers, heat transmission, dryers Emulsification machines, culture tanks, heat exchange equipment, exhaust/bio-chemical analyzers, solid preparations, cooling equipment, air compressors, filtration and separation, extraction, chromatography separation, distillation concentration, cell crusher, fermentation system control software, high pressure Homogeneity machine, water production, air purification and other water treatment, environmental protection equipment; third, the participants: pharmaceutical enterprises, pharmaceutical research and development, research institutes, medical institutions and other relevant professionals; pharmaceutical production enterprises responsible for process development personnel, quality management personnel, verification personnel, ministry of regulatory affairs personnel, The head of the production department, the workshop director and the relevant technical personnel, the deputy general manager of production, the project engineer, the project manager, the verification manager and the QA personnel.
Iv. Organizers: China Pharmaceutical Education Association Pharmaceutical Technology Professional Committee, Shanghai International Biofermentation Exhibition Organizing Committee Organizers: Beijing Rongzhi Feitian Education Technology Co., Ltd. Media Support: Zhi Pharmaceutical Circle, China Pharmaceutical Network Said Medical Equipment, China Information Network Sina, Today's Headline V, invited guest Ke First: Pharmaceutical Industry more than 15 years of work experience, senior engineer, International Pharmaceutical Engineering Association (ISPE) lecturer and member.
is familiar with the global GxP compliance regulations and guidelines, has been responsible for domestic large group companies and multinational pharmaceutical companies and other high-end standard project management implementation, gap analysis, GEP consulting, commissioning confirmation verification consulting, data integrity consulting, inspection support and defect correction activities.
is involved in the preparation, translation or collation of books such as the Pharmaceutical Process Verification Implementation Manual, the EU GMP/GDP Regulation Compilation (Chinese and English Control Edition), the Pharmaceutical Industry Manufacturing Implementation System Implementation Manual, the Global Data Reliability Regulatory Guide (Chinese and English Control Edition), and the ASTM E2500 Application Guide.
has published 10 professional papers and reports in the field of pharmaceutical compliance in the journals and media such as Process Industry, Electrical and Mechanical Information, China Pharmaceutical Daily and Furgo Industries.
obtained a number of pharmaceutical industry-related patents and software warrants.
participated in training and forum exchange activities such as the Drug Administration, ISPE, industry associations, universities and media organizations.
Schedule (Part I) Difficult analysis of the implementation of new pharmaceutical engineering projects August 27/09:00-09:301, regulatory compliance and early planning of new pharmaceutical projects, regulations, guidelines for new pharmaceutical projects, early stage of new pharmaceutical projects Planning August 27/09:30-10:30 II, Product/Process-Based, Risk-Based Pharmaceutical Project Good Engineering Management Practices , Product/Process-Based Approaches, Risk-Based Approaches, Good Engineering Management Practices August 27/10:30-10:40 (tea break) August 27/10:40-12:003, new pharmaceutical engineering project design, construction, commissioning/confirmation/verification, operation and maintenance. 27th/12:00-13:30pm (lunch) Part II: Key points of application and compliance of information automation technology in the pharmaceutical industry August 27th/13:30-14:30 4.0 Application Meaning: Information Automation Construction Concept: An Efficient And Holistic Approach Based on Risk and Science: The Status and Analysis of Automation Applications in Chinese Pharmaceutical Enterprises: Key Points of Application of Information Technology Compliance August 27/14:30-15:50 (Tea Break) (Tea Break) (Part III) Legacy/Transformation Or relocation project implementation difficulties analysis August 27 /14:50-16:30: The overall consideration of legacy/renovation or relocation projects and problems, legacy/renovation or relocation project implementation methods and difficulties, project decommissioning process (1) project decommissioning strategy (2) project decommissioning implementation