Why Should You Attend:
If you do not have sufficient controls and oversight of your contract manufacturers, you run the risk of not being alert to issues that surface at the contractor and being able to respond quickly enough to prevent significant economic and regulatory disaster. During inspection time, a lack of oversight will be viewed by the agency as a significant regulatory finding resulting in a warning letter or worse.

Areas Covered in the Session: This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the. We will walk you through successful contract manufacturing strategies and logistics. This includes a check list of the common issues encountered when working with service providers.

• What is the logical sequence of events
  
• When should you audit and who should audit
  
• Will you need a contract and a Quality agreement
  
• What should this agreement contain
  
• What are the tell tale signs things are going wrong
  
• When do you negotiate responsibilities
  
• What does a success contract manufacturing relationship look like
  
• What does an effective communication plan look like

Who Will Benefit:

• QA and Compliance Staff
  
• Regulatory Affairs Staff
  
• Manufacturing Staff
  
• validation
  
• Senior Management