Medical Device Supplier Control and Outsourcing

– Should a CMO apply ours, or their own, procedures?
– Can I let my subcontractor both write and approve the process validation plan?
– What should be included in the quality agreement?

If you sometimes struggle with this type of questions, this training is for you!

Course description

The MDR has high expectations on control of resources, not least supplier controls. Your contract manufacturer, or suppliers of other outsourced services, is among your most important partners, and the way you select and interact with them has a huge impact on your ability to get to, and stay on, the market. Yet there is limited information in standard and guidance documents on how to establish and maintain control. In this training you will receive both tools and examples of best practice and learn how use the ‘Plan – Do – Check – Act approach’ to control and verify the performance of your suppliers.

Learning objectives

 At the end of this course, participants should have a better understanding of

• How to define relevant criteria for supplier selection
• Risk management and risk-based approach in relation to suppliers and CMO’s.
• Critical aspects of the agreement between legal manufacturers and contract manufacturers
• How to involve and make use of knowledge of the supplier already during the early development process (build a sustainable partnership)
• Product life cycle perspectives, how to establish a change control process in relation to the supplier (ECR/ECO), and how to manage a change of supplier.
• Make justified decisions on scope and objectives of supplier audits

Course outline

• Outsourcing versus purchasing? Definitions and why it matters.
• Definition of roles (including OEM/OBL, PLM and Virtual Manufacturers).
• Establish criterias and perform, and document, supplier selection.
• When and how to involve you contract manufacturer in the design & development process
• Quality agreements – recommended contents and how to use it to ensure control.
• Design transfer when working with a CMO – how much information, and in which format?
• Roles and responsibilities in Supplier Risk Management
• The responsibility of the PRRC in outsourcing
• Ongoing monitoring and periodic re-evaluation
• Handling deviations and changes
• Supplier Audits, when and how?
• Ending/transferring the agreement
• Regulations worldwide

Who should attend

Anyone involved in selection, control, or cooperation with suppliers

Need of prior knowledge/experiences

• You should have basic knowledge in development and/or production of medical devices
• You should have at least 6-12 months experience of medical device industry.

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