The 24 Elements You Need for a World-Class Quality Agreement

An FDAnews On-Demand Webinar

Offered for One Day Only, Friday, Dec. 16, 2016
11:00 a.m. - 12:30 p.m. EST

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:

  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
  1. Subcontracting
  2. Dispute Resolution
  3. Technical Transfer
  4. Validation / Qualification
  5. Warehousing and Distribution
  6. Record Retention
  7. Sample Retention
  8. Reprocessing / Reworking
  9. Supplier Qualification
  10. Stability Programs
  11. Contact List
  12. Responsibility Matrix

Use this 24-point plan to make sure you’ve covered all your bases and keep your suppliers well in hand.

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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


Meet Your Presenter

Steven Sharf, ASQ-CQA, CPGP

Senior Consultant,

Steven Sharf has spent over 20 years in the pharmaceutical industry working on supplier quality management for such companies as Novartis, Merck, and Schering-Plough. Prior to coming on as Senior Quality Consultant for Validant, he was president of GMP Concepts and GMP technical director for SQA Services. He has managed multiple regions simultaneously covering thousands of suppliers and over a hundred auditors and has worked on multiple consent decrees as an assessor/inspector and a verifier. He has presented on numerous occasions to different industry groups regarding the principles and philosophies he employs when evaluating suppliers and audit programs in general.

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