Lean FDA Supplier Management & Auditing

Get help from the expert who trained FDA & Health Canada officials

Our managing director wrote the two US RAPS certification courses on supplier management and taught regulatory health agencies how to quickly determine if a company’s supplier management program is effective, especially when it comes to virtual companies as suppliers.  John Avellanet has written and spoken widely on how to balance business constraints with regulatory requirements, chaired multiple industry conferences, and shown hundreds of executives what works and what doesn’t when it comes to supplier quality management in the 21st century.


  • Risk-based, supplier selection, evaluation, qualification & monitoring program design and SOPs
  • Compliance with FDA, ICH, IMDRF, and ISO requirements
  • Supplier due diligence audits – perfect for supplier data integrity audits
  • Practical, time-tested techniques to qualify and oversee virtual companies in your supply chain
  • Expert review of quality agreements
  • Supply chain control mapping
  • Practical, defensible audits of clinical suppliers and critical QSR/cGMP suppliers
  • Pragmatic advice on technology tools for supplier and materials quality
  • Corporate workshops and SOP revisions to incorporate risk-based, streamlined controls
  • Experienced help from an industry expert who’s trained FDA officials and spent a career managing suppliers around the world

Call +1 757 645 2864 or email us to ensure your supplier management is on track