Effective Utilization and Management of Contract Development and Manufacturing Organizations (CDMO’s)

Many organizations utilize CDMO’s for part or all of their CMC drug development work.  This can include process development, analytic development and qualification, drug substance manufacturing, drug product manufacturing, QC, and stability programs.  This course will describe how to identify, evaluate, select, and manage CDMO’s for drug development projects.  The identification, evaluation, and selection process for a project CDMO needs to be planned with the establishment of criteria for each step.  The types of contracts that must be put in place between the sponsor and service provider will be described and examples will be provided.  Once the project is initiated effective project management must be utilized by the leaders to ensure the timely and within budget completion of the project.

The subjects covered are:

• Project scope definition
• CDMO Evaluation
  > Identification
  > “Fit to project”
  > Compliance and regulatory actions
  > RFP’s
  > Site visits
• CDMO Selection
  > Selection criteria
  > Fit
• Contracts
  > Master service agreements
  > Project contracts
  > Supply agreements
  > Quality or technical agreements
• Management and project execution
  > Project management
  > Roles and Responsibilities
  > Steering Committees
  > Expectations and priorities
  > Methods of communications
  > Budgets and timelines
  > Change control/orders
  > Deliverables
  > Quality Assurance Roles
• Conflict resolution