3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

Date : 24th February 2021 to 24th February 2021

Place : United States, Clyde

Website :https://worldcomplianceseminars.com/

Contact Person:WCs Conference

Description:

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS) will be held in Clyde,United States on date 2021-02-24

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Deadline for abstracts/proposals : 24th February 2021

Keynote Speakers : Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.

Conference Highlights :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 Session 2: Testing the hypotheses regarding potential root causes Retesting Considering Other Batches Session 3: Developing a proper CAPA plan

Check the event website for more details.