Identification and Management of OOT and OOS Results - Live Online Training

27 September 2022

Course No. 20159



Dr. Joachim Ermer

Dr. Joachim Ermer

Ermer Quality Consulting

All times mentioned are CEST.


Out-of-specification (OOS) test results and their appropriate management is an important topic in pharmaceutical Quality Control and inevitably in the focus of any inspection and audit. The purpose of the seminar is providing an overview on regulatory expectations, which are mainly based on the FDA Guidance for Industry “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production”, as well as practical recommendations for a GMP-conform investigation.


Although the FDA-Guidance on OOS-results provides detailed instructions how to manage results outside specification, observations and deficiencies dealing with OOS results is still a major issue in inspections, FDA 483s and Warning Letters.

In the speaker’s experience, an important aspect is to establish a clear terminology to facilitate understanding of the investigation phases and the appropriate testing approaches.

Of course, “prevention is better than cure”. For this purpose, it is important to avoid OOS-results, for example by means of a suitable identification of atypical or out-of-trend (OOT) results. The participants will learn how to identify OOT-results and how to establish suitable OOT-limits

Target Group

This Live Online Training is aimed at executives and employees from quality control, quality assurance, production, regulatory and audit functions who want to gain a better understanding of the GMP requirements for the management of OOS-results and how to establish OOT-limits to better prevent OOS-results.

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Identification and Management of OOT and OOS Results - Live Online Training

Seminar Programme as PDF

Definition of OOT and OOS Results
  •  Regulatory “out-of” definitions
    •  atypical, suspect, out-of-trend, out-of-expectation, out-of-specification
  •  Reportable value
  •  Error types (random, systematic)
    •  How can they be distinguished?
  •  Normal or abnormal?
    •  (Normal) distribution of data
Establishing OOT Limits for Release Testing
  •  Statistical approaches
  •  Empirical approaches
  •  Control charts
Establishing OOT Limits for Stability Testing
  •  Impact of OOT results in stability studies (ICH studies, ongoing stability)
  •  Introducing a second dimension (“normal” stability trend)
  •  Statistical approaches
    •  95% prediction interval of the linear regression
    •  Regression control chart
    •  Time-point method
Management of OOT and OOS Results in the Quality Control Laboratory
  •  FDA Guidance and European requirements (EU GMP Guide, MHRA, PIC/S)
  •  Importance of a clear terminology (reportable value, re-analysis, retest, re-sampling)
  •  Investigation pathway: OOS identification & decisions
  •  Phase I: Initial laboratory investigation
  •  Phase II: Full scale investigation           
    •  Phase IIA: Review in production
    •  Phase IIB: Additional laboratory testing (retests, averaging)
  •  Variability and OOS
  •  Reporting and documentation
  •  Appropriate response to OOS observations in inspections
Evaluation and commenting of OOS examples

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

Woman with headset

Go back

Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024


“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023