This one day course is designed to be a highly interactive exploration of best practice for OOS investigations in a GMP environment.
The course is aimed at the investigation of all out of expectation (OOE) results, including out of specification (OOS), out of trend (OOT) and any atypical, aberrant or anomalous result. For convenience, the term OOS is used in the following information but all OOE results will be covered in the course.
Course overview:
The course explores the process for investigation of OOS results and the different phases of investigation, and also best practice investigation skills for effective and scientific OOS investigations. This includes:
The learner will be able to:
This course is suitable for:
Laboratory staff who are responsible for leading OOS investigations and everyone associated with analysis in the pharma laboratory who may be involved in an OOS investigation.
For example:
The agenda for this live online training option is spread over 2 days (09:00 to 15:00 on day 1 and 09;00 to 11:00 on day 2). The time zone for live online courses is based on BST (UTC+1) from April to October.
The course is aimed at the investigation of all out of expectation (OOE) results, including out of specification (OOS), out of trend (OOT) and any atypical, aberrant or anomalous result. For convenience, the term OOS is used in the following information but all OOE results will be covered in the course.
Course overview:
The course explores the process for investigation of OOS results and the different phases of investigation, and also best practice investigation skills for effective and scientific OOS investigations. This includes:
- Following a scientific rationale,
- The expectations of regulatory authorities,
- Gathering available evidence,
- Generating potential hypotheses,
- Testing those hypotheses,
- Performing root cause analysis, using appropriate and effective techniques and tools.
The learner will be able to:
- Comprehend the significance of investigating OOS results effectively.
- Understand the process for investigation of OOS results through the phases defined by regulatory authorities such as FDA and MHRA.
- Formulate appropriate hypotheses regarding potential assignable causes for OOS results.
- Conduct effective and scientific OOS investigations using appropriate techniques and tools.
- Effectively evaluate data resulting from OOS investigations.
- Perform root cause analysis for laboratory failures which lead to OOS results and design relevant CAPAs to prevent reoccurrence.
This course is suitable for:
Laboratory staff who are responsible for leading OOS investigations and everyone associated with analysis in the pharma laboratory who may be involved in an OOS investigation.
For example:
- Analysts
- Reviewers
- Supervisors
- Managers
- Comprehensive course hand-outs - The training book is posted to the attendee prior to the event.
- Certificate of Attendance
- Optional post training assessment (accessed in e-MTS) which leads to a Certificate of Training.
- Access to training materials via e-MTS
- Post training support – Attendees can contact the trainer with questions that may occur when they apply their learning to real life situations.
The agenda for this live online training option is spread over 2 days (09:00 to 15:00 on day 1 and 09;00 to 11:00 on day 2). The time zone for live online courses is based on BST (UTC+1) from April to October.
