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Conducting Effective Investigations of Atypical and Out of Specification Laboratory Results
Tuesday, July 31, 2012 from 10:00 AM to 12:00 PM
Palo Alto, CA
This 2-hr session will provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
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
- Evaluating the Outcomes: Is there an assignable cause?
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.