Properly Investigating and Remediating OOS Results
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Website ProperlyInvestigatingandRemediatingOOSResults |
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Category Biotechnology , Pharmaceutical
Deadline: February 25, 2016 | Date: February 25, 2016
Venue/Country: Online, U.S.A
Updated: 2016-02-09 19:14:37 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis 90-minute accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.Course Outline :Guidelines for Detecting an OOS or Atypical ResultDefinition Atypical or Out of Specification Result?Review of the FDA Guidance for Industry on Investigating OOS Test Results- Phase I: Initial Laboratory Investigation- Phase II: Full Scale InvestigationRoot Cause Analysis Methods- 5 Whys- Flow Charts- Checklists- Fishbone DiagramsTesting the hypotheses regarding potential root causes - Retesting- Considering Other BatchesDeveloping a proper CAPA plan to address any Corrective Actions- How to properly document findings - Example of a proper OOS investigation write upLearning Objectives :Learn the responsibilities of Analysts and SupervisorsListen to what the FDA looks for in terms of Human ErrorsDescribe when a Full Investigation should be triggeredDescribe the frequency for Re-testing and Re-samplingLearn how to implement the corrective and preventive action plans (CAPA)Who Should Attend:Lab Analysts, Supervisors and Managers in Pharmaceutical or Biological Laboratories, including Quality Control and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment. Webinar Includes:Q/A Session with the Expert to ask your questionHandouts (PDF print only copy of PowerPoint slides)90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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