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 quality agreements, improve communication, prepare for audits, manage batch release, or plan the safe transfer of product and process knowledge to another site.

This course gives you a practical framework for 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 the sponsor and the partner, how to plan and conduct audits, and how regulatory obligations such as batch release and QP responsibilities 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 management, 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.

The course spans two days with an overnight stay, which provides time and space for reflection, immersion, and networking across participants—and thereby significantly enhances your overall learning outcomes.

Your benefits

• You can assess and select partners based on maturity, competence, and risk.
• You can prepare and follow up on quality agreements, create clarity on roles and responsibilities, handle audits, manage batch release activities, and understand QP obligations.
• You can plan and manage a technology transfer in phases with clear tasks and deliverables, manage knowledge transfer, and identify and mitigate risks.you can assess and select partners based on maturity, competence and risk.

Your company's benefits

• Your employees can strengthen the company’s control of CMO, CDMO, and CRO partnerships and reduce risk in outsourced activities.
• Your employees can support stronger quality agreements, clearer responsibilities, and better collaboration across QA, QC, QP, RA, and manufacturing.
• Your employees can run technology transfers in a more structured way, helping the company improve quality, compliance, and supply security.