ComplianceOnline, Online Event
2013-07-16
Why Should You Attend: Upon completion of this course the attendee should: - 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.
Areas Covered in the Seminar: - 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
- Retesting
- Evaluating the Outcomes: Is there an assignable cause?
- Documenting the Investigation.
- Utilizing Outcomes for Continuous Improvement.
- Questions and Discussions.
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Invited Speakers:
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Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.
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