CMOs give you a manufacturing edge. That’s why you take them on. But then too often you find yourself in a management morass — getting unsatisfactory results, wasting precious time and resources, even skirting with regulatory violations.
Maybe it’s time for a fresh approach — a quality systems-based relationship rather than the piecemeal management style that drags down so much of drug, device and diagnostics manufacturing.
Mark your calendar for the workshop where you discover all that — and more.
You’ll spend two days in intense hands-on learning with ValSource COO Hal Baseman and his team of experienced instructors (who have worked on both sides of the contract giver and acceptor equation). They’re steeped in quality systems, aseptic processing, validation, training, contamination control and running a CMO. You’ll go home armored with your own plan to build and managed a risk-based lifecycle model custom-tailored to your needs.
Here’s just a sampling of what you’ll discover:
- What to include in quality agreements: ‘Must have’ vs. ‘nice to have’
- Working with a CMO using a hazard identification tool (HIT)
- Regulatory citations: Who is responsible — you, or the CMO?
- Monitoring and auditing your CMOs
- Team-building: Participation from the owners’ organizations and CMOs (plant-in-plant concepts)
- Joint effective and efficient deviation investigation techniques
- Creating a checklist: Key items to consider when working with a CMO
- Avoiding and resolving conflicts between client company (“contract giver”) and CMO (“contract acceptor”)
- Communication information to comply with process validation and health authority expectations
- And much more!
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.
The venue is the Hilton Garden Inn in Center City Philadelphia, surrounded by great restaurants, shopping, and the rich history associated with this cradle of American independence. Consider adding on a day, or a weekend, to enjoy Philly’s many charms.
New to CMOs? Unhappy with things as they are? 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.