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Unhappy with your Contract Manufacturing Organizations (CMOs)?

Do you need a fresh look at relationships that wither without constant attention?

Maybe, it’s time for a fresh approach with your CMO — a quality-system-based relationship rather than the piecemeal management style that drags down so much of drug, device and diagnostics manufacturing.

You’ll spend two days in a hands-on learning environment with ValSource’s COO Hal Baseman and Director James Vesper. They’re steeped in quality systems, aseptic processing, validation, training, contamination control and running a CMO. You’ll go home equipped with your own plan to build and managed a risk-based lifecycle model custom-tailored to your needs.

This highly interactive workshop has been developed to help you ask critical questions to set up a systematic assessment and strong risk-free contracts:

  1. What’s in your quality agreement?  Have you included when you are to be notified of a surprise health authority inspection? What else is important?
  2. Have you used a structured approach to consider CMO risks?  How are you reducing the significant risks?
  3. Who is responsible for compliance — you? The CMO?  Both of you?  What do the regulations say?
  4. When can you visit your CMO?  How often?  When should you?
  5. What happens when your CMO tells you “human error” is the cause of a deviation?  Do you accept that?
  6. How can you consistently evaluate and compare potential CMOs?  How can you use a risk-based approach with a checklist?
  7. How can you best avoid conflicts between your company (“contract giver”) and the CMO (“contract acceptor”)?  When there is a conflict, how do you work it out?
  8. How can you make this relationship a win-win for you and your CMO? 

Special Free Bonus Materials

  • Presentation Slides and workshop handouts
  • Copies of Applicable FDA Regulations
  • Copies of Applicable FDA Guidance Documents
  • Relevant international guidance documents
  • Relevant, selected book chapters from GMP in Practice by J. Vesper
  • Hazard identification tool (HIT) template
     

Plan on making time for networking. Your fellow attendees will be drug, device and diagnostics makers facing the problems you face. They’re eager to know your solutions, and to share theirs.

View the full workshop schedule

Unhappy with your CMO? Maybe you simply need a fresh look at relationships that wither without constant attention. Whatever your situation, this conference helps you and your team shape a leaner, more profitable manufacturing situation. Register TODAY.

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