Qualification and Management of Contract Manufacturing Organizations (CMOs)

Every pharmaceutical company hopes to obtain their desired expectations when it comes to important relationships with their Outsourcing Partners. This intensive course examines the root causes of critical issues that can arise within these relationships which are much broader and deeper than the technical capability to perform a process. This intensive 12-hour, accredited course, delivered over three consecutive days examines the strategic and tactical outsourcing processes of selecting, monitoring, and managing an outsourced operation. It includes a review of domestic and international regulatory requirements and operational aspects including the role of the quality system. An in-depth discussion of risk-based supplier and material qualification processes, supplier selection, supplier monitoring, contracts/agreements, and auditing will be presented. In addition, the course examines how best practices of project management can transform an outsourcing schedule into a true project plan. The course includes hands-on workshops in which mini teams analyze case studies and present their findings.