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 20947

 

Costs

This training/webinar cannot be booked. To find alternative dates for this training/webinar or similar events please see the events list by topic.

For many training courses and webinars, there are also recordings you can order and watch any time. You can find these recordings in a list sorted by topic.

Or simply send us your inquiry by using the following contact form.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Melanie Distl, Roche
York Moeller, J.A.Moeller Chongqing
Mukesh Patel, CommQP
Philipp Reusch, Reuschlaw
Wolfgang Schmitt, Concept Heidelberg
Dr Franz Schönfeld, GMP Inspector
Dr Reto Theiß, Merck Healthcare

Objectives

During this course, you will learn all relevant aspects to implement 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 increase 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?

Starting materials should only be purchased from approved suppliers. But also in contract manufacture and analysis, the contract giver is responsible for assessing the legality, suitability and the competence of the contract acceptor to follow GMP (EU Guide to GMP [7.5]).

The requirements and efforts to qualify suppliers should therefore not be underestimated. However, it seems that a downright ‘audit tourism’ has grown and suppliers and service providers are audited 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 personnel involved in supplier qualification activities at their company and decision makers who want to improve the existing process. It is addressed to persons from Quality Assurance and Control, Procurement, Business Development, Manufacturing, Project Management and R&D.

Programme

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
  • 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
Interactive Session:
a) Supply Chain Risk Assessment for China
b) Auditing in India
- Challenges and pitfalls
- What to look for
- Infrastructure and Transportation issues

Go back

GMP Conferences by Topics