Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Duration: 90 Minutes
This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Objectives of the Presentation
Upon completion of this course the attendee should:
Why Should you Attend
- Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations
- Be familiar with the FDA Guidance for industry on investigating Out-of-Specification (OOS) test results for pharmaceutical production and how to apply it in laboratory situations
- Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results
- Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs
- Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results
Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that are out-of-specification or outside of statistically expected ranges.
Who will Benefit
- What constitutes an atypical or out of specification result?
- The Barr decision of 1993 and its impact on OOS investigations
- The FDA Guidance for industry on investigating OOS test results
- Reporting data
- Conducting the investigation
- Creating an investigation checklist
- Considering other batches
- Evaluating the outcomes: Is there an assignable cause?
- Documenting the investigation
- Utilizing outcomes for continuous improvement
- Questions and discussions
The following personnel in pharmaceutical laboratories will benefit from this training:
- Supervisors and Managers
- Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
- GMP auditors
- Analysts and other laboratory staff
- Regulatory Affairs
- Product Development analytical testing Managers and Directors
- Product Development Analysts
- Quality Assurance Directors, Managers and record reviewers