Supplier Qualification for Pharmaceutical Manufacturer

December
03
2025 (Wednesday)
Time 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
3 Days Left To REGISTER
Id: 210412
Instructor
Nigel J Smart 
Live
Recorded
Live + Recorded
Refund Policy

Overview

This would describe how to build and operate a compliant supplier qualification process . Things to look for and do’s and don'ts.

Why you should Attend

Many manufacturers get into trouble by not properly qualifying their suppliers with the result that they receive FDA citations. This causes delays or problems when they are manufacturing clinical candidates or commercially license products. This can be a big source of disruption and lead to problems when it comes to regulatory submissions connected with those products/candidates.

Areas Covered in the Session

  • How to select candidate to qualify
  • The aspects of the suppliers business to consider developing a profile of
  • How to audit them 
  • How to assess their capabilities
  • What approval and disqualification issues to consider

Who Will Benefit

  • Manufacturing Purchase Groups 
  • Operations Staff and Quality Assurance Staff

Speaker Profile

Nigel J Smart PhD is the President of SMART Pharmaceutical Consulting, a West Chester, Pennsylvania, USA Life Sciences consulting firm.

He is a serial entrepreneur with decades of experience in the biotechnology/pharmaceutical industry; many of those based in North America in both corporate and consulting capacities. He consults on a variety of Life Sciences topics with particular interest in Lean and Performance strategies in Bioprocess Development/Manufacturing, in addition to the application of Quality Compliance principles to modern processes. In relation to these topics, he is particularly focused on digital applications associated with generating what he terms Powerhouse High Performance outcomes. In relation to Quality Compliance, Nigel has acted as an expert consultant for the FDA on cGMP and Data Integrity issues and assists both domestic and foreign companies with sustainable Quality Compliance strategies. As part of his government service, Nigel has assisted both the Biological Advanced Research & Development Authority (BARDA), and the Department of Defense in the relation to the production of anti-terrorist countermeasures. He has a special interest in the application of LEAN Process Excellence principles to Bioprocess Manufacturing systems and is the author of a book dedicated to this topic entitled “Lean Biomanufacturing” Oxford Health Publishers.
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