The 24 Elements You Need For a World-Class Quality Agreement - Webinar CD/Transcript

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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.

  • 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

Steven Sharf, ASQ-CQA, CPGP, Senior Consultant, Validant

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.