Blue Sky Approach - Down to Earth Solutions
Investigating OOS Results
Inadequate handling of investigations for Out of Specification (OOS) results are the cause of the majority of 483’s and regulatory observations. In October, 2006, the FDA released new guidelines to assist the industry. This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment in accordance with the FDA 2006 guidelines and the 2008 Health Canada GMP guidelines. The focus will be on those results generated during process manufacturing and laboratory testing including a step-by-step approach on how to conduct and document an OOS result investigation in compliance with an FDA or Health Canada audit. A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, determining the extent of the investigation during Phase I and Phase II, documenting findings and following up on corrective and preventative action plans.
This course is presented in a dynamic environment created by a Powerpoint presentation, interactive exercises, case studies and group discussion.
· Regulatory guidelines on OOS results and examples of warning letters
· Additional GMP documentation (quality systems) required to support OOS investigation
· Investigation approach
· Determining the root cause
· Responsibilities
· Documentation
· Corrective and Preventative actions and audit trail
· Minimising future OOS results
For more details contact : pauline@pmcgconsulting.com