World Conference Calendar

35118 Conferences

Out-of-Specification Investigations, Identifying the Attributable

Added by OCPcompliance on 2014-10-24

Conference Dates:

Start Date Start Date: 2014-11-19
Last Date Last Day: 2014-11-19
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2014-11-18

Conference Contact Info:

Contact Person Contact Person: David Jonathan Moses
Email Email:
Address Address: 38868 Salmon Ter, Fremont, California, 94536, United States, Fremont, CA, 94536, United States

Conference Description:

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. The objective of this webinar is 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 process. The discussion will be based on the FDA guidance on handling OOS laboratory results. This live webinar training is to provide a clear process for compliant laboratory OOS investigations.

Why Should you Attend:
Individuals should attend this webinar to gain an in-depth insight into the compliant investigation of OOS laboratory results.

Objectives of the Presentation:
This Live Presentation Will Cover:
The requirements for laboratory OOS investigations
Regulatory expectations
The laboratory OOS investigation process
Laboratory investigation, Phase I
Laboratory investigation, Phase II
Repeat testing
Communicating with Quality Assurance
Who can Benefit:
Quality Control Laboratory personnel
Quality Control laboratory supervisory and management personnel
Quality Assurance reviewers

Quick Contact:

Toll free: +1-510-857-5896
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA

Use For Registration: commerce/webinar/~product_id=500618?expD ate=Oct9_2014_Attributable
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