Back by popular demand – with a Special Offer!
Purchase the On-Demand webinar and save 50% on the 24 Elements of a Successful Supplier Quality Agreement briefing report.
Supplier quality is a topic of perennial importance. Today’s minor mistake could easily turn into tomorrow’s major recall. And if you don’t catch all the problems in your quality agreement, odds are the FDA will.
On Dec. 16 join Steven Sharf, a 20-year industry veteran who has managed thousands of suppliers for companies like Merck and Novartis for on-demand access to this popular webinar. He 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 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.
Please note; this webinar has been previously recorded and no questions will be taken during the presentation.
24 Elements of a Successful Supplier Quality Agreement
Do you want the confidence that you have your suppliers under control?
Would you like the ability to craft a supplier quality agreement that covers all bases?
How about a model for a quality agreement the FDA will approve?
In this FDAnews Brief, 20-year industry veteran Steven Sharf, explains the elements that need to go into your quality agreement:
- Calibration and Maintenance
- Batch Documentation
- Change Control
- Deviations / OOSs
- Field Alerts / Recalls
- Material Inspection / Testing / Release
- Labeling Controls
- Rejected Materials
- Complaint Handling
- APR / PQR Inputs
- Audits / Inspections
- Specifications
|
- Subcontracting
- Dispute Resolution
- Technical Transfer
- Validation / Qualification
- Warehousing and Distribution
- Record Retention
- Sample Retention
- Reprocessing / Reworking
- Supplier Qualification
- Stability Programs
- Contact List
- Responsibility Matrix
|
Use this 24-point plan to make sure you’ve covered all your bases and keep your suppliers well in hand.
Regular Price: $177
Save 50% with On-Demand Purchase: $88 |
