CMO Management and Technology Transfer in GxP

Working and collaborating with external partners such as CMOs, CDMOs, and CROs is a core element of many life science strategies and often brings practical challenges. You may need to clarify responsibilities, strengthen the quality agreements, improve communication, prepare audits, manage batch release or plan safe transfer of product and process knowledge to another site.

This course gives you a practical framework to handle these tasks of managing external partners and performing technology transfer in regulated environments in a structured and compliant way:

• You learn how to assess partner maturity, select the right CMO/CDMO/CRO, manage cultural and language barriers, and understand regulatory expectations for outsourced activities
• You learn how responsibilities are shared between sponsor and partner, how to plan and conduct audits, and how regulatory obligations such as batch release and QP responsibility are handled
• You also gain a structured approach to technology transfer from preparation to routine production.

The course takes you through the purpose, requirements, governance and phases of technology transfer so you can plan and manage a transfer from preparation to routine operation.

You work with risk, documentation, training, process and analytical transfer, verification and formal handover between sending and receiving sites.

This course alternates between short lectures, case work, and group exercises. This helps you turn theory into practical action and apply the principles directly in your daily work.

On the course you will meet:

Pourya Vali, Principal Consultant & Founder, Nordic GxP Compliance

Thomas Sølver, Expertise Director, NIRAS