In an era marked by evolving regulatory expectations and growing reliance on contract partners, the pharmaceutical industry faces increasing complexity when outsourcing manufacturing and testing. The FDA’s updated guidance on CGMP for outsourcing facilities – and its emphasis on quality agreements, data integrity, and shared responsibilities – highlights the urgent need for aligned strategies across contract manufacturers, testing labs, and sponsors.

This conference serves as your hub for mastering the regulatory, operational, and technical challenges of outsourcing pharmaceutical manufacturing and laboratory services. Learn from FDA-facing experts, global pharma leaders, and seasoned quality professionals as they share real-world strategies for building resilient partnerships, ensuring compliance, and safeguarding product integrity across the entire outsourced network.

Whether you’re working with a CDMO, contract lab, or both, this program offers critical takeaways for optimizing your approach, aligning with current guidance, and staying ahead of enforcement risk.

Top Reasons to Attend

1. Break Down the New FDA Draft Guidance: Understand the implications of recent guidance for outsourcing facilities, CDMOs, and contract labs
2. Explore Practical AI Tools for Oversight and Efficiency: Learn how sponsors and CDMOs use AI for supplier risk monitoring, document review, analytical data
3. Ensure Compliance Across Contract Partners: Learn how to build oversight systems that extend from manufacturing to testing
4. Navigate Global Regulatory Expectations: Address differences across FDA, EMA, MHRA, and other international agencies
5. Build Stronger Quality Agreements: Clarify responsibilities, documentation expectations, and audit readiness with partners
6. Streamline Tech Transfer and Method Validation: Implement best practices for method transfer and analytical testing
7. Strengthen Data Integrity and Traceability: Ensure robust documentation, chain of custody, and test result integrity
8. Mitigate Supply Chain and Testing Delays: Improve timelines and transparency with proactive contract management
9. Avoid Costly Deviations and Enforcement Actions: Learn what causes inspections to go wrong – and how to avoid it
10. Discover Best Practices from Across the Industry: Benchmark your practices against pharma and biopharma peers

Who Should Attend

This event is designed for professionals in:

• Manufacturing Operations
• Quality Assurance & Control
• Regulatory Affairs
• Validation & Engineering
• IT & Data Integrity
• Analytical and Microbiology Labs
• Sterility Assurance
• Contract Lab Management
• Supplier Quality & Auditing
• Strategic Partnerships & Outsourcing
• Program and Project Management