Dr Franz Schönfeld
Regierung von Oberfranken
Referent:innen
Dr Reto Theiß
Merck Healthcare
Philipp Reusch
Reusch Rechtsanwaltsgesellschaft
Mukesh Patel
CommQP Pharmaceutical Services
Dr Melanie Distl
F. Hoffmann-La Roche
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 increase 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?
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. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers brings new 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.
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. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers brings new 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 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.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
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 presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Timing and Duration:
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 presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programm
The Objective of Supplier Qualification
- Regulatory Background
- Duties and responsibilities of the QP
- Expectations of the authorities
- Importing Active Pharmaceutical Ingredients into the European Union
International Trade Relations – What you Need to Know
- International trade law
- Applicable commercial Legislation
- Jurisdiction
- Incoterms
- Responsibilities
GMP Pre-Requisites for Procurement and Outsourcing Activities
- GMP training for procurement staff
- Dealing with brokers
- Contracts
- Change Control
- Complaints
- Roles and responsibilities
Outsourcing to Contract Manufacturers and Laboratories - What Needs to be Considered and Who is Responsible?
- What activities can you out-source?
- Differences when outsourcing within the EU compared to outside of the EU
- Initiation and Contents of the Technical Agreements
- Validation activities: tasks and responsibilities
- GMP/GDP interface
- Legal and ethical responsibilities
- What can happen when things go wrong?
Case Studies:
When Things go Wrong
When Things go Wrong
- Quality Risk Management to avoid delivery bottlenecks and drug shortage
A Modular System for Qualifying and Maintaining Suppliers
- Integrating supplier qualification in the pharmaceutical quality System
- Interfaces with other Departments
- Examples
Reduced Testing of Supplied APIs and Excipients
- What guidance is available on reduced QC testing?
- EU and FDA expectations
- Information required before you start reducing
- Can APIs and excipients be covered within the same approach?
- Practical execution
Risk Management in the Supply Chain: Frequency of Supplier Audits based on Risk Assessment
An interactive session to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
An interactive session to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
- Frequency of Supplier Audits based on Risk Assessment
- Defining risk in the audit program
- Compliance risk assessment
Recording from 15/16 March 2023
Duration of the recording: approx. 8.5 hours
Duration of the recording: approx. 8.5 hours
| ECA-Member*: | € 1490,- |
| Regular Fee*: | € 1690,- |
| EU/GMP Inspectorates*: | € 845,- |
| APIC Member Discount*: | € 1590,- |
| QP Member Discount*: | € 1490,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor"
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E-Mail: info@concept-heidelberg.de
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