The 24 Elements You Need For a World-Class Quality Agreement - Webinar CD/Transcript
The 24 Elements You Need For a World-Class Quality Agreement
Supplier quality is a fundamental topic of perennial importance. Your agreements with suppliers must be written and executed to cover every possible contingency and ensure that the materials that go into your products are exactly what you require and are available when you need them. Today’s minor mistake by your supplier could easily turn into tomorrow’s major recall. And if you don’t catch all the oversights in your quality agreement, odds are the FDA will.
Steven Sharf, a 20-year industry veteran who has managed thousands of suppliers for companies like Merck and Novartis, explains the 24 elements that must be included in your quality agreement.
You’ll not only learn what the 24 elements are but you will also learn
- The importance of clearly defined roles in the complaint handling / adverse event reporting process
- The need for a responsibility matrix to clearly identify what entity is responsible for what quality function
- How many samples should your agreement require to be retained?
- Subcontracting and whether your company should allow it at the discretion of the subcontractor
Don't think that because there is no explicit (FDA) requirement for auditing your suppliers that you won't get written up in a heartbeat for not having a robust audit program and quality audits of your suppliers.
Your bottom line, your workforce, and your organization’s reputation will suffer due to a lack of supplier controls.