Supplier Selection, Qualification & Management – A Lean Compliance Toolkit

$349.00

Summary

FDA inspectors are increasingly scrutinizing how firms control their supply chains – from contract manufacturers, raw materials suppliers, and even professional services.  Recent 483s & warning letters have cited firms for failure to adequately qualify and control their suppliers.  And the FDAAA gives the agency the authority to fine individual executives and companies for poor oversight and control of suppliers.

This recorded seminar provides a practical, risk-based supplier oversight strategy based on the tenets of lean compliance – from initial supplier selection, through qualification, approval and long-term monitoring.  You will see how to effectively share the compliance burden, the steps necessary to ensure vendor accountability, and records required to minimize your risk.

Learning points

  • When an on-site audit is required … and when it’s not (and why)
  • How to prioritize suppliers and controls based on risk
  • Steps to address second-tier suppliers
  • What FDA inspectors will be looking for when it comes to vendor management & oversight
  • Supplier qualification program components that FDA investigators expect to see
  • Three crucial supplier lists you must maintain
  • Key tactics to share the regulatory compliance burden
  • How to handle virtual suppliers
  • Dangers of ignoring supplier records management & controls
  • A systematic methodology to select, qualify, approve and monitor suppliers

And much more

Get 11+ documents for easy & quick implementation

  • Checklist:  Do’s & don’ts for supplier quality agreements
  • Form:  Supplier (short-form) questionnaire
  • Sychronized audio-visual recording
  • Slides with room for your own notes
  • Case study:  Shared risk – a regulatory management strategy
  • FDA presentation on supply chains:  Barry Rothman, Pharmaceutical Ingredient Supply Chains
  • FDA presentation about supplier controls:  Kim Trautman, Supplier Controls – the FDA Medical Device Requirements
  • FDA presentation on contract manufacturing:  Jay Eltermann, Contract Manufacturing and Quality Agreements
  • FDA presentation on monitoring component suppliers:  Steven Wolfgang, FDA Perspective on Qualification and Monitoring of Drug Component Suppliers
  • FDA presentation on supplier harmonization regulations:  Kim Trautman, The GHTF Document on Supplier Controls

And more

How it works

Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.

Note: CD will be shipped after payment has been received. See our Better Business Bureau-accredited online purchasing and return policy for questions.

More benefits

  • Efficiency:  Elimination of travel means more affordable advice
  • Productivity:  Rely on technology tools to view the recorded seminar and get the reference materials
  • Veteran expertise:  Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
  • Environmentally sound:  Spare our environment with less travel and a digital download

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