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Conference Directory
Out-of-Specification Investigations - The laboratory
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: CA
Number of Attendees: Unknown
Webinar or Virtual Event: No
Keywords: Quality Control analysts,Quality Control record reviewers,Quality Control Supervisors,Quality Control Managers,Quality Assurance record reviewers,Quality Assurance Supervisors,Quality Assurance Managers,Personnel working with contract laboratories
Start Date of Conference:: 02-26-2010
End Date of Conference: 02-26-2010
Description of Conference: Why Should You Attend :
Although the FDA interest in how pharmaceutical firms handled out-of-specification laboratory results began more than fifteen years ago, OOS procedures and investigations are still a topic of FDA Investigator review with the result of continuing FDA 83 observations and Warning Letter citations.
An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how to handle an out-of-specification result should be handled and investigated.
This webinar will discuss out of specification result investigations, with a focus on activities in the laboratory.
The webinar will begin with a brief discussion of the background to the interest in OOS investigations and concentrate on a process, consistent with the FDA guidance, that will result in a compliant investigation of an out of specification laboratory result.
The webinar participants will learn the origin of the term out of specification and FDA concerns and opinions. They will be led through a process for the successful completion of OOS investigations.
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Out-of-Specification Investigations - The laboratory
