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 of the OOS investigation
• Reporting and evaluating passing and failing results
The importance of the GMP documentation required to support the OOS investigation is presented but the majority of time is spent detailing the who, what, when, how and why of the investigation, documenting findings and determining root causes to identify if the OOS is valid or can be assigned to analyst or laboratory error. Corrective and preventative actions are also discussed. An introduction to OOT (Out of Trend) results with respect to analytical and compliance alerts related to the laboratory is included, using industry examples in the first session of this course.
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.
Based on the FDA guideline 'Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production', October 2006, FDA audit observations and the current MHRA guidelines
The 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.
This course is not applicable to Microbiology methods.
• 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 of the OOS investigation
• Reporting and evaluating passing and failing results
The importance of the GMP documentation required to support the OOS investigation is presented but the majority of time is spent detailing the who, what, when, how and why of the investigation, documenting findings and determining root causes to identify if the OOS is valid or can be assigned to analyst or laboratory error. Corrective and preventative actions are also discussed. An introduction to OOT (Out of Trend) results with respect to analytical and compliance alerts related to the laboratory is included, using industry examples in the first session of this course.
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.
Based on the FDA guideline 'Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production', October 2006, FDA audit observations and the current MHRA guidelines
The 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.
This course is not applicable to Microbiology methods.
