The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE/OOT) Analytical Results

  • 2° EDITION: 10-17 May 2024
  • Online
  • Italian

Training overview

Part One – The investigation of out-of-specification and unexpected results
10 May 2024 Edition 2

The training course “The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE/OOT) Analytical Results” aims to provide the tools to identify and classify anomalies found in analytical data that may constitute an out-of-specification, out-of-trend, or unexpected finding. In the first part of the training, we will focus on how to conduct a structured survey and perform an effective RCA aimed at identifying the actual root cause. Besides, throughout the day, regulatory references will be provided and the proper requirements for an investigation that is in compliance with regulatory expectations will be explained in depth, providing examples from the literature.

Part Two – The CAPA plan, OOS in stability data management and from supplier
17 May 2024 Edition 2

In the second part of the course “The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE/OOT) Analytical Results” having acquired during the first part the necessary concepts for conducting a laboratory investigation related to out-of-specification results, we will focus on the management of the outlier data and its impact on the process/product. How to define an appropriate CAPA plan and effectiveness check will be examined. Then OOS results generated by third parties (suppliers, CMOs, analytical service providers) and the necessary actions (CAPA plan and follow up) towards suppliers will be addressed. In addition, OOS results from stability and consequent actions on the process/product and evaluation of regulatory impacts will be addressed.

Would you like to participate, but you’re not available on this date?
The course will be provided again:

  • October 15th and 25th 2024
  • March 7th and 14th 2025

(*) Contact us via email or phone to enroll.


Key points of the training

  • Identify and classify out-of-specification and abnormal results
  • Know the relevant regulations for handling OOS results
  • How to conduct a structured and effective investigation
  • Highlight on recurring regulatory observations (examples)
  • Manage nonconformities obtained on materials/products/analyses provided by external agencies
  • Manage OOS obtained from stability studies
  • Setting up an effective CAPA plan
  • Monitoring the effectiveness of the CAPA plan (effectiveness check)


09:00 – 13:00 COURSE SESSION

Part 1: The investigation of out-of-specification and unexpected outcomes: 10 May 2024 Edition 2


  • Course presentation, purpose, expectations
  • Specific definitions and terminology

Regulatory references and requirements:

  • What GMP requires when dealing with out-of-specification results
  • Presentation of the MHRA guideline
  • FDA guideline presentation
  • Sample observations from regulatory audits pertaining to investigation of OOS results

The laboratory investigation:

  • Initial investigation
  • Officialization of the OOS data
  • Management of related batches
  • Conclusion of the laboratory investigation

The extended investigation:

  • Root causes analysis: methodologies and tools
  • Modalities of in-depth laboratory investigation
  • When and how to conduct an interdepartmental investigation
  • Evaluation of survey data and conclusion

The survey of OOE/OOT data

Discussion and questions


Part 2: The CAPA plan, OOS data management in stability and from supplier: 17 May 2024 Edition 2

09:00 – 13:00 COURSE SESSION

Nonconformity from Supplier:

  • Management of abnormal results obtained on raw materials, intermediates or SMF/PF prepared by external workshops
  • Management of abnormal results obtained from external laboratories performing commissioned analysis
  • Follow-up of CAPA plans defined and implemented by the supplier
  • Impact on risk factor and audit plan

Anomalous data in stability studies: investigation and FAR (field alert report)

  • Impact on the process/product
  • FAR (field alert report) for the US market.
  • Assessment of regulatory impacts

CAPA plan definition:

  • Periodical review: periodic trends in OOS and OOTs
  • dentification and analysis of root causes
  • Identification of immediate corrective actions and actions to remove root causes
  • Plan for monitoring the effectiveness of CAPA action plans

Discussion and questions

Test with correction

Quality Control, Quality Assurance, Validation team, Chemical and formulation development, Production, Regulatory Affairs, Engineering, Supply Chain.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Susanna Del Ciotto

Susanna Del Ciotto

GMP trainer and auditor

She is graduated in Chemistry at the University of Parma and she has been working in the pharmaceutical sector for about 20 years. She held positions of responsibility in the QC sector as Head of the Laboratory for Stability Studies, Development and Validation of Analysis Methods, Chemical Laboratory for the control of MPs, and finally as QC Manager. She currently works as a trainer and consultant for GMP alignment, resolution of non-conformities, laboratory investigations, preparation and conduct of Audits with a particular focus on the management of inspections by the AIFA and FDA regulatory bodies.

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Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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