This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.
This course is teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner. The course will examine actual situations as case studies, with students guided in effective investigation resolution, and required to perform effective investigations, and determine proper solutions to effect proper corrective action.
Key Considerations in effective “Root Cause” and CAPA Analyses.
FDA’s Out-Of-Specification Guidance, and US requirements for effective investigations.
Out-Of-Specification (OOS), Out-Of-Trend (OOT), Out-Of-Expectations (OOE) incidents.
Tools for Effective Investigations:
Why Should You Attend:
When unexpected events happen - you cannot follow an SOP and need to deviate from it, or you obtain an out-of-specification test result, or your supplier’s raw materials marginally fails specification and you desperately need the material - what do you do? A few years ago, the standard reaction to an unexpected event was either to ignore it, it might go away, or to fix it. Today such reactions are unacceptable when working in a GMP environment. Not only do you need to investigate the event to determine what happened, but you need to figure out why the event happened, and then to resolve the event in a manner that prevents its recurrence. Not only is this sound GMP, it also makes good business and economic sense.This course is teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner. The course will examine actual situations as case studies, with students guided in effective investigation resolution, and required to perform effective investigations, and determine proper solutions to effect proper corrective action.
Areas Covered in the seminar:
- GMP requirements for failure investigation in the US, EU, and Canada.
- How do the GMP authorities want you to investigate failures and quality events?
- Being “In Control” - Essentials of a Corrective Actions and Preventive Actions (CAPA) program.
Key Considerations in effective “Root Cause” and CAPA Analyses.
FDA’s Out-Of-Specification Guidance, and US requirements for effective investigations.
Out-Of-Specification (OOS), Out-Of-Trend (OOT), Out-Of-Expectations (OOE) incidents.
Tools for Effective Investigations:
- Ishikawa (Fishbone) Analyses
- Pareto Analysis
- Documentation of Investigations.
Case studies:
- Laboratory Out-Of-Specification Incidents
- Manufacturing Failures
- Manufacturing Deviations
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:- End-users responsible for applications that need to be validated
- QA managers and personnel
- Production Managers and production staff
- QC Lab Managers and QC analysts
- Consultants
- Quality system auditors
Course Provider
Michael Anisfeld,
