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Do you want the confidence that you have your suppliers under control?
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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?
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.
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
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- Subcontracting
- Dispute Resolution
- Technical Transfer
- Validation / Qualification
- Warehousing and Distribution
- Record Retention
- Sample Retention
- Reprocessing / Reworking
- Supplier Qualification
- Stability Programs
- Contact List
- Responsibility Matrix
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Use this 24-point plan to make sure you’ve covered all your bases and keep your suppliers well in hand. Order your copy today.
PDF Edition
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Available Format |
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PDF Edition — $177
Who Will Benefit
- Auditors
- Compliance officers
- Engineering and design controls teams
- Executive management
- Managers
- Manufacturing directors and supervisors
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- Risk management specialists
- Strategic planning and business development staff
- Validation specialists, scientists, engineers
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
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