FDAnews Announces — News Brief — 24 Elements of a Successful Supplier Quality Agreement

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Quality agreements with suppliers must be written and executed to cover every possible contingency and ensure that the materials that go into a product is exactly what is required and available when needed. In this FDANews Brief, 24 Elements of a Successful Supplier Quality Agreement, 20-year industry veteran Steven Sharf, explains the elements that need to go into a quality agreement.

24 Elements of a Successful Supplier Quality Agreement

**An FDAnews Brief**

http://www.fdanews.com/24ElementsSuccessfulQualityAgreement    

Supplier quality is a fundamental topic of perennial importance.

Quality agreements with suppliers must be written and executed to cover every possible contingency and ensure that the materials that go into a product is exactly what is required and available when needed.

Today’s minor mistake by a supplier could easily turn into tomorrow’s major recall. And if manufacturers don’t catch all the oversights in a 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 a quality agreement:

1.    Calibration and Maintenance
2.    Batch Documentation
3.    Change Control
4.    Deviations / OOSs
5.    Field Alerts / Recalls
6.    Material Inspection / Testing / Release
7.    Labeling Controls
8.    Rejected Materials
9.    Complaint Handling
10.    APR / PQR Inputs
11.    Audits / Inspections
12.    Specifications
13.    Subcontracting
14.    Dispute Resolution
15.    Technical Transfer
16.    Validation / Qualification
17.    Warehousing and Distribution
18.    Record Retention
19.    Sample Retention
20.    Reprocessing / Reworking
21.    Supplier Qualification
22.    Stability Programs
23.    Contact List
24.    Responsibility Matrix

Use this 24-point plan to make sure all the bases are covered and keep suppliers well in hand.

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

FDAnews Brief Details:

24 Elements of a Successful Supplier Quality Agreement
Price: $177
http://www.fdanews.com/24ElementsSuccessfulQualityAgreement    

Easy Ways to Order:

Online: http://www.fdanews.com/24ElementsSuccessfulQualityAgreement            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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