Pre-Course Session: What you need to know about Suppliers in China and India - Live Online Training

Wednesday, 25 June 2025 9 .00 - 17.30 h

Course No. 21563

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Speakers

York Moeller

York Moeller

Moeller Consulting

Mukesh Patel

Mukesh Patel

CommQP Pharmaceutical Services

All times mentioned are CEST.

Objectives

During this course, you will learn all relevant aspects to imple- ment and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements. Furthermore, you will get to know possibilities and tools to in- crease efficiency and decrease costs at your company.

Background

Qualification and audits of suppliers, contract manufacturers and laboratories and other service providers are an important part of each Quality System. But what is required and which steps are really necessary? And is it possible to even decrease audit activities?

The requirements and efforts to qualify suppliers should not be underestimated. However, it seems that a downright ‘audit tourism’ has grown and suppliers and service providers are au- dited sometimes too often. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers brings other challenges. This adds up to significant expenses for both the audited and the auditing company.

But supplier qualification is not limited to auditing. The whole process of supplier qualification and co-operation should be integrated in the existing Quality System of a company.

Target Group

This course and its pre-course session are designed for all per- sonnel involved in supplier qualification activities at their com- pany and decision makers who want to improve the existing pro- cess. It is addressed to persons from Quality Assurance and Control, Procurement, Business Development, Manufacturing, Project Management and R&D.

Technical Requirements

We use Webex Events for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

Pre-Course Session: What you need to know about Suppliers in China and India - Live Online Training

Seminar Programme as PDF


Sourcing from Asia: What Procurement and QA should Know
  • ƒTrading 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
  • Decision making inside companies
  • How to find out who is really in charge
  • The Translator - chances and 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 form 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
Examples:
a) Supply Chain Risk Assessment for China
b) Auditing in India
  • Challenges and pitfalls
  • What to look for
  • Infrastructure and Transportation issues
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.

ECA-Member*: € 890,-
Regular Fee*: € 990,-
EU/GMP Inspectorates*: € 495,-
APIC Member Discount*: € 945,-
QP Member Discount*: € 890,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023