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

PROGRAM

09:00 – 13:00 COURSE SESSION

Part 1: The investigation of out-of-specification and unexpected outcomes: 11 December 2023 Edition 1 | 23 February 2024 Edition 2

Introduction:

• 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: 12 December 2023 Edition 1 | 1 March 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 info@pharmaeducationcenter.it 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 info@pharmaeducationcenter.it. 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.