Pre-course Session: What you need to know about suppliers in China and India

Pre-course Session: What you need to know about suppliers in China and India

Barcelona, Spain

Course No 9078


Costs

This conference already took place.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Richard M. Bonner, ECA, formerly with Eli Lilly
Ian Holloway, Medicines & Healthcare Products Regulatory Agency (MHRA), UK
York Moeller, J. A. Moeller Chongqing, China
Mukesh Patel, CommQP
Philipp Reusch, Reusch Attorneys
Wolfgang Schmitt, Concept Heidelberg

Dr Reto Theiß
Merck KGaA

Programme

Pre-course Session: What you need to know about suppliers in China and India

Sourcing from Asia: what Procurement and QA should know
Trading company or manufacturer – how do I know?
Different manufacturing sites – was the right one audited?
Transport Qualification
Typical GMP Issues of Chinese plants
What to consider when auditing a plant

India and China: Cultural Aspects to consider when doing Business
Meeting people for the first time - what to do and what not to do
Guanxi - Chinese word for “relationship” - relationship vs contract
How are decisions made inside companies
How to find out who is really in charge
The translator - noticing limits

The Indian and Chinese Pharma Market: an overview (legal structures, authorities)
Overview about size and number of companies
What documents make a company legal
What different forms of companies do exist
CFDA - what are their powers, what are their limits
The Chinese Tax and VAT system and its effect on purchases from China

Inspections in Asia
Challenges and pitfalls
What to look for
Infrastructure and Transportation issues

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