Wolfgang Schmitt, Concept Heidelberg
Dr Georg Sindelar, msg industry advisors AG
During this Online Training, you will learn the most important 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.
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. EU Directive 2004/27/EC states that the manufacturer shall only use active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials. 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 on site frequently and sometimes too often. 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.
This Online Training is designed for all personnel involved in supplier qualification activities at their company and decision makers who want to improve the existing process.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
09.00 – 09.15 h
09.15 – 10.10 h
Duties and Responsibilities
- Regulatory background (EU, ICH, FDA)
- Duties and responsibilities
- Importing APIs into the EU
- Remote Audits
10.10 – 10.30 h Break
10.30 – 11.30 h
Outsourcing to Contract Manufacturers and Laboratories
- Points to consider
- Which activities can be outsourced - and how
- Outsourcing outside the EU
- Validation – tasks and responsibilities
- When things go wrong – problems and conflict solving
11.30 – 12.15 h
Efficient Supplier Qualification – A Risk-based Approach
- What is risk?
- Tools that could be used in the qualification process
- Examples for risk assessments in supplier qualification
12.15 – 12.45 h
Live Q&A Session
12.45 – 14.00 h Break
14.00 – 14.45 h
Suppliers of Packaging Material and Excipients
- Applying formalised Risk Assessments
- Risk classification and Supplier Qualification
- Solutions for audit request rejections
14.45 – 15.00 h Break
15.00 – 15-30
- Different Types of Contracts
- Parties and Signees
- Staying compliant by staying up to date
15.30 – 16.00 h
Live Q&A Session