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.
Objectives
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?
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.
Programme
Programme Education Course: Efficient Supplier Qualification 15/16 April 2026
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
Programme pre-course Session: What you need to know About Suppliers in China and India 14 April 2026
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
Interactive Session:
a) Supply Chain Risk Assessment for China b) Auditing in India
Challenges and pitfalls
What to look for
Infrastructure and Transportation issues
Further Information
Venue for both events Barceló Hotel Hamburg Ferdinandstraße 15 20095 Hamburg, Germany +49 (0)40 22 63 62 0
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
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.
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.
Conference language The official conference language will be English.
Testimonials
