Testing and NSF to hold cGMP training meeting for dietary supplements

Business news on November 20 detailed explanation of CGMP regulations for dietary supplements and analysis of laboratory test standards time: December 20-22, 2012 location: Shanghai NSF dietary supplement service NSF dietary supplement service is oriented to the dietary supplement industry, focusing on the continuous improvement of quality system, improving the knowledge level of employees, providing analysis and testing to help enterprises meet the regulatory requirements of the United States and the world At NSF, our distinguished scientists will share with you the rich experience and knowledge of the dietary supplements and pharmaceutical industry Our team can help you solve the most difficult quality control, method development and regulatory compliance issues Course introduction 1 Detailed explanation of FDA act 21cfr111 this course is not only applicable to all-round in-depth analysis of the course including FDA act, but also case analysis based on the latest warning letter involving non-compliance with 21 CFR 111 GMP 2 Explanation of capa This course focuses on the relevant factors and methods to help you turn the possible adverse events in cGMP system, such as customer complaints, product non-compliance with requirements, non-compliance with specific operations, supplier problems, internal audit / second party or third party audit results and other issues into good results, so as to ensure to avoid the recurrence of similar problems and strengthen the whole quality control system You will also be informed of key roles and responsibilities in the CAPA process 3 Interpretation of international test standards this course aims at the plant extract enterprises exporting to European and American markets to help enterprises understand how to control product quality and avoid risks through the interpretation of various international test standards related to the quality control of plant extract products 4 Explanation of quality management code of conduct in laboratory 17025 this course helps enterprises effectively manage the normal operation of their own laboratories by explaining the quality management code of conduct in laboratory 17025 Quality and technical personnel: QA / QC, production department, engineering department, regulatory affairs department, laboratory, and other relevant personnel; as part of 21 CFR 111 compliance, dietary supplement production personnel must undergo this training course Upon completion of the course, a certificate of completion will be issued You will be informed that through the explanation and examples of each regulatory chapter of fad dietary supplement cGMP, you can understand how to comply with the terms and discuss the latest FDA warning letter to dietary supplement enterprises, and evaluate the non-compliance items with the regulatory conflicts This paper introduces the composition and key points of the CAPA system, and how to reply to the FDA's investigation report on the latest development of the international testing standards for dietary supplement enterprises Through the 17025 standard of the laboratory, we can effectively manage our own enterprises On the first day, December 20, Thursday, 8:30-16:30 training topic: detailed explanation of the FDA act 21cfr111 Lecture expert: Lam Keng Siak / lanqinxi, brief introduction of NSF international Trainer: explain and discuss the contents of CGMP regulations of dietary supplements in the United States, analyze the regulatory compliance in high-risk areas of dietary supplement enterprises through factory examples, and conduct case analysis according to the latest FDA warning letter involving non-compliance with 21cfr111 GMP Next day, Friday, December 21, 9:00-16:30 training topic: explanation of CAPA expert: Lam Keng Siak / Mr LAN Qinxi, trainer of NSF International Content introduction: This paper briefly introduces the definition, composition and key points of CAPA in cGMP system of dietary supplements to effectively avoid adverse events, and how to name data sources, define unexpected events and handling methods, analyze and discuss activities related to CAPA process The third day, December 22, Saturday, 9:00-12:00 training topic: explanation of international test standards and 17025 quality management code of conduct expert: Ms Liu Dongjing, NSF China Laboratory Manager content brief introduction: by analyzing the product requirements of European and American markets for plant extract industry, explain in detail the international test standards related to quality control of plant extract products, In order to help enterprises control quality problems and avoid risks more effectively, 17025 quality management code of conduct was explained Mr Lam Keng Siak / LAN Qinxi, lecturer, and Lam Keng Siak, trainer of NSF international, graduated from the National University of Singapore with a Bachelor of Science degree and Nanyang University of technology with a master of Business Administration degree Obtained the ASQ (American Quality Association) pharmaceutical production quality management professional certificate (certified pharmaceutical GMPP professional) He is a certified trainer and assessor with the Singapore workforce development authority He was the head of production and quality for the Asian region at the US pharmaceutical company The pharmaceutical factory he managed was once recognized by the Singapore pharmaceutical Council as a GMP training workplace He has more than 30 years of extensive pharmaceutical work experience, including on-site inspection of GMP regulatory authorities at home and abroad He is currently a consultant of NSF international in Asia, focusing on GMP training and on-site audit Ms Liu Dongjing, manager of NSF China Laboratory, holds a master's degree in chemistry from osnabrueck University in Germany and a bachelor's degree in pharmaceutical chemistry from Peking University Medical Department She has more than 10 years of experience in chemistry, medicine and management Now he is the manager of NSF China Laboratory If you attend this training course, please fill in this form and fax it to 021-52389971 and transfer it to Chen Rongqing for collection, or scan this form and email it to achen@nsf.org for course fee ① cGMP regulation training fee: RMB 2400 / person (including 20 day and 21 day training materials fee, venue fee, expert fee, lunch fee and certificate fee, etc.) ② laboratory management training fee: RMB 600 yuan / person (including 22 day training materials, venue, experts and certificate fees, etc.) ③ accommodation and travel expenses of the delegates are at your own expense Preferential information: ① 85% discount for NSF's existing customers; ② 85% discount for payment before December 7; ③ 85% discount for three or more participants in the same unit Payment method account name: Shanghai Hebang Certification Co., Ltd Bank of deposit: Industrial and Commercial Bank of China Shanghai Yan'an west road sub branch account number: 1001 2786 0901 6252 914 note: after remittance, please fax the bank remittance receipt to our company, 021-52389971, Or email achen@nsf.org for details, please refer to the training session topic: www.testrust.com/palert/zt-28.html