Advanced CMO Management: Selection, Qualification, and Operational Excellence

Summary

In today’s dynamic pharmaceutical and biopharmaceutical industries, outsourcing to Contract Manufacturing Organizations (CMOs) is a critical strategy to boost efficiency, scalability, and compliance. Successful partnerships require a structured approach to selection, qualification, and ongoing management to safeguard product quality, regulatory compliance, and business success. This comprehensive course dives deep into the EU and US Good Manufacturing Practice (GMP) requirements, equipping participants with the tools and best practices needed to establish and maintain high-performing CMO relationships.

Learning Objectives

• Regulatory Framework: Gain a thorough understanding of EU and US GMP requirements for contract manufacturing, including EMA, FDA, and ICH guidelines.
• Strategic CMO Selection: Learn to identify and evaluate contract manufacturing partners based on compliance, technical capabilities, and strategic alignment.
• Risk-Based Qualification: Implement a structured risk assessment approach to effectively qualify CMOs before engaging in partnerships.
• Audit Best Practices: Understand how to conduct GMP audits and due diligence to assess a CMO’s compliance status and operational maturity.
• Quality Agreements: Learn how to draft, negotiate, and implement robust quality agreements that define clear responsibilities and compliance expectations.
• Contract Negotiation: Develop skills to ensure that contracts cover key legal, financial, and operational aspects to protect both parties’ interests.
• Technology Transfer Excellence: Explore best practices for seamless knowledge transfer, process validation, and scale-up when working with CMOs.
• Performance Monitoring: Establish key performance indicators (KPIs) and review mechanisms to measure and manage CMO performance effectively.
• Supply Chain & Logistics: Understand how to ensure efficient supply chain coordination, including material sourcing, lead times, and inventory management.
• Ongoing Compliance Management: Learn strategies for continuous oversight, deviation management, and maintaining a state of GMP compliance.
• Handling Quality & Regulatory Issues: Develop a proactive approach to managing deviations, complaints, recalls, and regulatory inspections involving CMOs.
• Change Control & Continuous Improvement: Implement robust change management processes to adapt to evolving regulatory and business needs.
• Crisis Management & Contingency Planning: Prepare for and mitigate risks related to supply disruptions, regulatory non-compliance, or operational failures.
• Case Studies & Real-World Applications: Gain insights from industry best practices, case studies, and lessons learned from successful and challenging CMO partnerships.
• Stakeholder Collaboration: Enhance communication and collaboration with internal teams and external partners to drive long-term success in contract manufacturing.

Key Topics

• Understand the regulatory landscape governing contract manufacturing in the EU and US, including GMP expectations from the EMA, FDA, and ICH guidelines.
• Learn a systematic approach to selecting the right CMO based on technical capabilities, compliance history, and strategic alignment.
• Master the qualification process, including due diligence, risk assessment, and audit methodologies.
• Develop strategies for contract negotiation, ensuring clear roles, responsibilities, and quality agreements.
• Gain insights into effective CMO oversight, performance monitoring, and compliance management throughout the product lifecycle.
• Explore case studies and real-world examples to apply best practices in contract manufacturing partnerships.

Who should attend?

CMO Procurement Manager; CMO Supply Chain Manager; Business Development Manager; QA Manager; QC Manager; Regulatory Affairs Professional; Contract Manufacturing Manager; R&D Project Manager; R&D Quality Manager; Clinical Project Manager; CMO Technical Operations & Manufacturing Lead; Compliance and GMP Auditor

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Digital and LinkedIn certificates