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    Properly Investigating and Remediating OOS Results

    View: 213

    Website http://c2gowebinars.com/product/?topic=oos-results-cycle | Want to Edit it Edit Freely

    Category Biotechnology , Pharmaceutical

    Deadline: February 25, 2016 | Date: February 25, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-02-06 19:58:36 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This 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 Result

    Definition 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 Investigation

    Root Cause Analysis Methods

    - 5 Whys

    - Flow Charts

    - Checklists

    - Fishbone Diagrams

    Testing the hypotheses regarding potential root causes

    - Retesting

    - Considering Other Batches

    Developing a proper CAPA plan to address any Corrective Actions

    - How to properly document findings

    - Example of a proper OOS investigation write up

    Learning Objectives :

    Learn the responsibilities of Analysts and Supervisors

    Listen to what the FDA looks for in terms of Human Errors

    Describe when a Full Investigation should be triggered

    Describe the frequency for Re-testing and Re-sampling

    Learn 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 question

    Handouts (PDF print only copy of PowerPoint slides)

    90 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.