Efficient Supplier Qualification - Live Online Training

26/27 June 2025

Course No. 21565

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Speakers

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken

Dr Reto Theiß

Dr Reto Theiß

Merck Healthcare

Philipp Reusch

Philipp Reusch

Reusch Rechtsanwaltsgesellschaft

Mukesh Patel

Mukesh Patel

CommQP Pharmaceutical Services

Dr Melanie Distl

Dr Melanie Distl

F. Hoffmann-La Roche

Wolfgang Schmitt

Wolfgang Schmitt

CONCEPT HEIDELBERG

All times mentioned are CEST.

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?
 
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.

Target Group

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 Requirements

We use Webex 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.

Programme

Efficient Supplier Qualification - Live Online Training

Seminar Programme as PDF

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
Risk Management in the Supply Chain: Frequency of Supplier Audits based on Risk Assessment
  • Frequency of Supplier Audits based on Risk Assessment
  • Defining risk in the audit program
  • Compliance risk assessment
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
Examples and Interaction:
Quality Risk Management in the Supply Chain
  • Expectation of the Regulators
  • Risk assessments
  • Interactive Session
  • Frequency of supplier audits based on risk assessment
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.

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This course is part of the GMP Certification Programme "ECA Certified GMP Auditor" Learn more

ECA-Member*: € 1490,-
Non ECA Member*: € 1690,-
EU/GMP Inspectorates*: € 845,-
APIC Member Discount*: € 1590,-
QP Member Discount*: € 1490,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
Further dates on-site
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Further dates online
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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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