Wolfgang Schmitt
CONCEPT HEIDELBERG
Referent:innen
Dr Reto Theiß
Merck Healthcare
Mukesh Patel
CommQP Pharmaceutical Services
Philipp Reusch
Reusch Rechtsanwaltsgesellschaft
Dr Franz Schönfeld
GMP Inspektor
Dr Melanie Distl
F. Hoffmann-La Roche
Further links: Pre-Course Session Suppliers from China and India on 14 April 2026 in HamburgPre-Course Session Suppliers from China and India AND Efficient Supplier Qualification on 14 & 15 and 16 April 2026 in Hamburg
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.
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?
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 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.
Hintergrund
Wed, 15 April 2026, 9:30–17:45 h
Thu, 16 April 2026, 9–15:30 h
Thu, 16 April 2026, 9–15:30 h
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.
Venue
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg, Germany
+49 (0)40 22 63 62 0
hamburg@barcelo.com
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg, Germany
+49 (0)40 22 63 62 0
hamburg@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/ POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
Pre-course Session: What you need to know about suppliers in China and India
ECA Members € 1,090
QP Association Members € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 645
Pre-course Session: What you need to know about suppliers in China and India
ECA Members € 1,090
QP Association Members € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 645
GMP Education Course: Efficient Supplier Qualification
ECA Members € 1,890
QP Association Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
Save money when booking both events. We offer you a discount of 400 Euro if you will book both training courses.
The conference fee is payable in advance after receipt of invoice and includes dinner on 15 April, lunch on all days and all refreshments. VAT is reclaimable.
Social Event
On 15 April, you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
The conference fee is payable in advance after receipt of invoice and includes dinner on 15 April, lunch on all days and all refreshments. VAT is reclaimable.
Social Event
On 15 April, you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 (0)6221 84 44 13, schopka@concept-heidelberg.de
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
- Procurement
- Objectives & priorities
- EU GMP Chapters and GMP processes applicable to Procurement
- GMP Training for the Buyer - Suppliers
- Supplier qualification
- Contracts
- Supplier categorisation
- Use of Brokers
Outsourcing to Contract Manufacturers and Laboratories - What Needs to be Considered and Who is Responsible?
- Regulatory Framework
- Regulations
- Outsourcing EU vs non-EU
- What if it goes wrong? - Outsourcing Life-Cycle Management
- Elements of Supplier Qualification
- Risk Assessment
- Technical Agreements
- Audits
Examples and Interaction: Quality Risk Management in the Supply Chain
- Expectation of the Regulators
- Risk assessments
- Interactive Session
Quality Risk Management in the Supply Chain: Frequency of Supplier Audits based on Risk Assessment
- Defining risk in the supplier qualification Programme
- Planning supplier audits based on risk assessment
- Compliance risk assessment
- Examples
Case Studies: Qualifying and Maintaining Suppliers at Roche
- Supplier Management embedded in PharmaTechOps and PQS
- Interface with other Departments
- Example – Risk-based approach to Supplier Management at Roche
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
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und SponsoringmöglichkeitenTeilnehmerstimmen - das sagen andere über unsere Seminare:
