THE first high level GMP Expert seminar will take place in Shanghai, China  on the 18th and 19th of November 2010.   gemro services Ltd. – the Chinese representative of gempex – a GMP consulting company with its main location in Mannheim, Germany is  organising this seminar.

Gemro was founded in May 2005 as a consultancy joint venture between He-Ro Chemicals Ltd and gempex GmBh.  Its primary focus is to provide high level GMP services onsite to clients in China. This includes working for  domestic companies but much more so for the western pharmaceutical industry and its interests in China . The catalyst for this joint venture came from well known European customers who repeatedly asked for  these kind of services.

Together with He-Ro, who has more than 25 years of experience in China and offices in HongKong, Guangzhou, Shanghai, and Tianjin, gemro today offers important GMP related services such as: 3rd party audits, follow-up services, compliance consultancy, design reviews for new production plants, qualification management, documentation reviews, training, and much more. These services are provided by local Chinese experts as well as by western consultants and GMP experts. This excellent combination – the cooperation of Chinese and German experts – results not only in attractive pricing for our clients but also in high quality services because GMP knowledge and experience is implemented with qualified local assistance and knowledge.

After carrying out a training workshop especially designed for the Chinese SFDA in November 2009 whose purpose was  to clarify and identify key critical differences and gaps between Chinese and Western GMP, gemro now is going to start a series of high level GMP Expert seminars which will close the identified gaps and to help western companies to find the same GMP standard as they are used to  from western sites.

The main topics for this first GMP Expert seminar include
( but are not limited to) :

• Inspection requirements that arise from western authorities
• Main differences between EU/ US GMP and PR China GMP
• Risk Assessment and Risk Management
• Change Management
• CAPA
• … and much more !

During this first seminar also there will be one speaker from the Shanghai SFDA who is well experienced in GMP inspection.  She will discussing the upcoming new Chinese GMP regulations and compare them to the previous Chinese regulations. These new guidelines will be valid from end of 2010.  Most of the new requirements are closer to  those Western regulations than previous.

If you would like more information or if you want to register somebody for this seminar, please contact directly Mr. Ralf Gengenbach on
r-gengenbach@gempex.com or visit our website www.gemro-services.com    

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