Workshop on Handling of OOS Test Results (FDA&MHRA)

  • Written by Chief Editor Tue, 14 Jun 22 PM
Events

Inadequate investigation of out of specification(OOS) results in the laboratory is common observation cited in FDA483s and warning letters.

This workshop organized by pharma coach Bhaskar Napte with the aim to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation practices.

The interactive live discussion will be based on the FDA&MHRA guidance on handling OOS laboratory results and to provide a clear process for compliant laboratory OOS Investigations

 Topics of the Workshop include

ü  Latest regulatory expectations on OOS

ü  The OOS investigation process

ü  Phase I,II&III investigation

ü  Additional laboratory testing

ü  Batch disposition decision

ü  FAR &Quality Defect report

ü  Outliers tests(statistical evaluation)

ü  Key elements to avoid OOS

The workshop will take place on Wednesday, 15th June 2022, from 08:00 pm to 10:30pm (IST)

For more the registration to the workshop please click here