This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment. 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 determining root causes and assigning corrective and preventative actions. An introduction to OOT (Out of Trend) results and an overview of the different types and how they are typically handled is also discussed using industry examples in the first session of this course.
This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.
The workshop emphasizes practical issues such as:
What is an OOT?
· The importance of good quality support systems
· FDA audit observations and how they could have been avoided
· Case studies for OOS results
· A detailed guide to conducting Phase 1 and Phase II of the OOS investigation
· Reporting and evaluating passing and failing results
The course provides ample opportunities for group discussions, case studies and
exercises. It enables participants to gain the skills and knowledge necessary to
meet current regulatory expectations. The course material is based on the FDA
guideline “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical
Production”, October 2006
This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.
The workshop emphasizes practical issues such as:
What is an OOT?
· The importance of good quality support systems
· FDA audit observations and how they could have been avoided
· Case studies for OOS results
· A detailed guide to conducting Phase 1 and Phase II of the OOS investigation
· Reporting and evaluating passing and failing results
The course provides ample opportunities for group discussions, case studies and
exercises. It enables participants to gain the skills and knowledge necessary to
meet current regulatory expectations. The course material is based on the FDA
guideline “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical
Production”, October 2006
