York Moeller
Moeller Consulting
Referierende
Mukesh Patel
CommQP Pharmaceutical Services
Zielgruppe
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.
Zielsetzung
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 in- crease efficiency and decrease costs at your company.
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.
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.
Programm
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
Examples:
a) Supply Chain Risk Assessment for China
b) Auditing in India
a) Supply Chain Risk Assessment for China
b) Auditing in India
- Challenges and pitfalls
- What to look for
- Infrastructure and Transportation issues
Weitere Informationen
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Conference Language
The official conference language will be English.
Contacts
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Recording from 25.06.2025
Duration of the recording: 5h 27m
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
| European QP Member Discount*: | € 1090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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