Handling Non-Compliance Situations

December
10
2025 (Wednesday)
Time 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
9 Days Left To REGISTER
Id: 210415
Instructor
Nigel J Smart 
Live
Recorded
Live + Recorded
Refund Policy

Overview

The session will describe how to handle situations where non-conformances arrive to  be handled and how better corrective actions and preventive solutions can be developed to minimize these issues.

Why you should Attend

Many people still fail to handle these issues effectively with the result there are negative comments from the regulatory agencies like the FDA. 

This causes a lot of wasted time fixing issues and this cause issues both in product development and commercial manufacturing. Whats required is an effective way to handle these quickly and use mechanisms that will irreducate most of the problems from recurring.

Areas Covered in the Session

  • Root Cause Analysis 
  • Use of Tools
  • Mindset to Problem Solving
  • Designing Appropriate CAPA Solutions

Who Will Benefit

  • QA and Manufacturing 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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