Inspection Readiness

December
16
2025 (Tuesday)
Time 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
15 Days Left To REGISTER
Id: 210417
Instructor
Nigel J Smart 
Live
Recorded
Live + Recorded
Refund Policy

Overview

Covers the processes required to prepare a site for inspection before a regulator arrives. Thereafter how to conduct the process once the regulator is on site.

Why you should Attend

Many companies are under preparing for regulatory inspections and as a result are being caught out with avoidable citations or negative results that could affect a licensing situation. 

This wastes both time which is significant and raises the cost of getting the product either into clinical trials or licensed for the market.
This reduces the uncertainty around moving a product forward through the developmental process and into the market place. 

Areas Covered in the Session

  • Site preparation
  • Includes constructing an audit team and a document repository team
  • Covers preparation of answers for questions
  • Covers who should run the process and why
  • Covers who should respond to questions
  • Covers how to respond to questions and dos and don’ts
  • Cover the meetings and close out meeting
  • Covers post audit actions

Who Will Benefit

  • Manufacturing Staff
  • QA and QC Staff
  • Project Managers
  • Senior Management Team

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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