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As supply chains become more global, issues surrounding quality are increasingly on the minds of drug suppliers and their vendors. SGS has developed this series to address issues that concern many multinational as well as local pharmaceutical companies. The series aims to provide useful information on topics such as method validation and analytical transfer to the current trends and global perspectives on stability studies. The final seminar in the series provides some insight on how to prepare for an FDA inspection. The seminar will cover three talks in three cities and a lot of useful insights.
Venues: Guangzhou
YuanYang Hotel
No. 6 TianHe LongKou Dong Lu
Guangzhou
Oct 13, 2008
Shanghai
SGS-CSTC Shanghai Branch, 3rd Building, No. 889
Yishan Road, Xuhui District
Shanghai
Oct 15, 2008
Beijing
19F Century YuHui Mansion,
No. 73, Fucheng Road, Haidian District
Beijing
Oct 17, 2008
Topics: “How to host an FDA inspection”
Presented by Angela Moy, SGS Life Science Services, Global Head of QA (GMP/GLP) (PDF 169KB)
FDA presented their plan to establish 3 permanent offices in China to monitor medical devices, drug and food safety. This presentation focus on 1) type of FDA inspections 2) system based cGMP inspection including SOPs, inspection team and 3) how to host an inspection: from the inspector’s arrival, to communication during the visit, to the meeting’s conclusion.
“Stability studies from global perspective and current updates”
Presented by Ulrich Markens, SGS Life Science Services, VP/Regional Manager Asia Pacific
( PDF 298KB)
Stability studies provide data support in drug substance/products re-test period, shelf life and storage condition, etc. The presentation covers reason for conducting stability tests, stages of stability studies, climatic zones and how to conduct a successful stability test.
“Method validation and analytical method transfer”
Presented by Ulrich Markens, SGS Life Science Services, VP/Regional Manager Asia Pacific
( PDF 298KB)
Analytical method validation is the process of documenting that analytical procedures are suitable for their intended use and method transfer is the process that qualifies a lab to use an analytical test procedure. The presentation includes the guidelines and procedures including preparation, plan and final report.
Costs: 500 CNY for 1 attendant
400 CNY each for attendants more than 2
View the China Seminar Tour Days Agenda. (PDF 51KB)
Register today to reserve your space for the
2008 China Seminar Series on Pharma Issues.