Webinars>>​FDA Compliance>>GMP and GLP
FDA Rules for Investigating Out-of-Specification (OOS) Test Results 

One of the most common observations cited in the FDA 483s and warning letters is inadequate investigation of out-of-specification results in GCLP or GMP laboratories. The OOS could be in a test results for a clinical assay or for an analytical release assay. Either way, the OOS must be investigated in a way compliant with the applicable FDA regulations. OOS investigations are also linked to the repeat assays and residual testing. A lot of confusion surrounds the FDA expectation regarding handling and investigation of an out-of-specification result and to deal with FDA audit findings.
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This webinar will help you understand how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The focus will be on the FDA guidance and suggestions for a process that will meet the FDA expectations.

Areas Covered in the Session:​
  • The requirements for laboratory OOS investigations
  • FDA Regulatory expectations
  • Trends in FDA findings for improper OOS investigation
  • The laboratory OOS investigation process
  • Retesting
  • Resampling
  • Communicating with Quality Assurance
Who will benefit:​
  • Quality Control labs
  • GLP, GCLP and GMP Lab technicians
  • Senior management
  • Production management
  • Quality management
  • Quality assurance managers and supervisors
  • Regulatory professionals
  • Quality control managers, supervisors and analysts
Date: April 12, 2021
​Time: 3 PM EST    Duration: 60 Minutes

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com