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This course is designed to be an 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 results. 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,
• Interpretation of hypotheses testing using appropriate statistical tools,
• Performing root cause analysis, using appropriate and effective tools and techniques.

Learning Objectives

1. Comprehend the significance of investigating OOS results effectively.
2. Understand the process for investigation of OOS results through the phases defined by regulatory authorities such as FDA and MHRA.
3. Formulate appropriate hypotheses regarding potential assignable causes for OOS results.
4. Conduct effective and scientific OOS investigations
5. Effectively evaluate the data resulting from OOS investigations using appropriate techniques and tools.
6. Perform root cause analysis for laboratory failures which lead to OOS results and design relevant CAPAs to prevent reoccurrence.

Attendees are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.

Delivery

This course is delivered as a 2 half day 'virtual' live online training event, which is delivered over a 3 hours and 45 minutes period on each day, from 9am to 12:45pm, including a short break. The time zone is typically based on GMT (UTC) from November to March, and BST (UTC+1) from April to October.

This course is suitable for anyone who is involved in an OOS (or similar) results investigation, including those who are responsible for leading the investigation. The focus of the content is on the analytical aspects of the investigation, rather than manufacturing. For example:

• Quality Control (QC) analytical chemists
• Quality Control (QC) managers/ supervisors
• Quality Assurance personnel

Course Fees