York Moeller
Moeller Consulting
Referent:innen
Mukesh Patel
CommQP Pharmaceutical Services
All times mentioned are CEST.
Zielsetzung
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.
Hintergrund
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.
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
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
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.
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,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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