How to properly investigate OOS/OOT Results

MessageThis Webinar is over
Date Jul 28, 2017
Time 12:00 PM EDT
Cost $159.00
The speaker will 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.
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.
Why Should You Attend
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations
Areas Covered in this Webinar
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
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 Will Benefit
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Quality Control Laboratory Staff
For more detail please click on this below link:
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510


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