Handling Non-Compliance Situations
Date:
Wednesday, December 10, 2025
Time:
10:00 AM PST | 01:00 PM EST
Duration:
60 Minutes
More Trainings by this Expert
Product Id : 508042
Price Details
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 should you 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.
