Investigating Out of Specification (OOS) Results

This course is designed to be an exploration of best practice for OOS investigations in a GMP environment, in compliance with FDA and MHRA guidance.


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.

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.

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.

Total learning time = 7 hours

More about total learning time

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.
How is this course delivered?

This course is delivered as a 2 day ‘virtual’ live online training event which is delivered over a 3 hours and 45 minutes period on each day, including a short break, typically from 9am to 12:45pm (but may depend on your time zone).

More about live online training

Total learning time = 7 hours

More about total learning time

The full agenda is provided in the course description.

The course may also be delivered as in-house training, either in the live online format or in a classroom based format at your site. In-house training allows customisation to meet your specific requirements.

More about in-house training

Who will deliver this training course?

All training courses are delivered by the MTS consultant, Oona McPolin. Some recordings of MTS webinars are provided below as examples of Oona’s presentation style.

Strategies for HPLC Method Development
Webinar Recording This webinar explored the different strategies, and combinations of strategies, which may be applied during HPLC method development. …
Where do the Acceptance Criteria in Method Validation Come From?
Webinar Recording One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance …
Who should attend this course?

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

When can I attend this course in 2024?
  • Thu 21st to Fri 22nd Mar 2024 (9am to 12:45pm GMT/UTC)
  • Thu 23rd to Fri 24th May 2024 (9am to 12:45pm BST/UTC+1)
  • Thu 25th to Fri 26th Jul 2024 (9am to 12:45pm BST/UTC+1)
  • Thu 24th to Fri 25th Oct 2024 (9am to 12:45pm GMT/UTC)
  • Tue 17th to Wed 18th Dec 2024 (9am to 12:45pm GMT/UTC)
How much does it cost?

£475 GBP or €550 EUR

Included in your course fees:
  • Comprehensive course hand-outs – The training book is provided as an electronic copy (pdf) for both live online and classroom based options.
  • Certificate of Attendance
  • Optional post training assessment (accessed in e-MTS, our learning management system) 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.
  1. All prices are quoted per person excluding VAT.
  2. VAT notice for live online training: For UK business cutomers and non-business customers (B2C) from all countries VAT is charged at the UK rate (currently 20%). For EU business customers (B2B), the reverse charge can be applied on receipt of a valid VAT identification number and VAT will not be charged. For business customers outside of the UK and EU, VAT will not be charged.
Cancellations and Substitutions

Once made and accepted by MTS, course bookings are liable for payment. Payment is due at least 14 days prior to the course start date. Cancellations prior to 3 weeks before the course date are subject to an administration charge of 25%. Cancellations received less than 3 weeks before the start of the course will not be refunded, although substitutions may be made at any time.

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid.

5 Golden Rules for Effective (and Inspection Ready) OOS Investigations
The investigation of out of specification (OOS) results is a regulatory requirement in a GMP …