Efficient Supplier Qualification - Live Online Training
17/18 March 2027
Course No. 22826
Speakers
Dr Franz Schönfeld
GMP Inspector
Dr Reto Theiß
Merck Healthcare
Philipp Reusch
Reusch Rechtsanwaltsgesellschaft
Mukesh Patel
CommQP Pharmaceutical Services
Dr Melanie Distl
F. Hoffmann-La Roche
Target Group
Personnel involved in supplier qualification and decision-makers seeking to improve existing processes
Intended for professionals from QA/QC, Procurement, Business Development, Manufacturing, Project Management and R&D
Objectives
Learn the key aspects of implementing and improving a comprehensive, integrated supplier qualification system that fulfils regulatory GMP requirements. You will also learn about options and tools to increase efficiency and reduce costs in your Company.
Background
Supplier Qualification and audits of suppliers, contract manufacturers, laboratories and other service providers are an important part of every quality system. But what is required, and which steps are really necessary? Is it even possible to reduce audit activities?
Programme
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.
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members EUR 1,890 QP Association Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference Language The official conference language will be English.
Participant Feedback from previous Courses: „I really enjoyed the topics, the way all the presentations have been structured as well as the way the questions have been answered.” Madalina Batista, IDT Biologika “Very good content”, Fabiana Frech
Date & Time
Wed, 17 March 2027, 09:00–16:45 h Thu, 18 March 2027, 09:00–15:30 h All times mentioned are CET.
Testimonials
