Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

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Deadline: April 25, 2019 | Date: April 25, 2019

Venue/Country: U.S.A

Updated: 2019-04-03 20:27:42 (GMT+9)

Call For Papers - CFP

This webinar will point out some of the goals of effective investigations, and how you can use Root Cause Analysis and Corrective and Preventive Actions to accomplish these goals.

Upon completion of this course the learner should be able to:

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 finding the true root cause and some techniques to assist in finding it.

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.