OOS, Out-Of-Specification Laboratory Results

MessageThis Webinar is over
Date Sep 13, 2017
Time 10:00 am
Cost $ 150.00
Online
Overview:
The objective of this webinar is to develop an understanding of how a 

compliant laboratory handles the investigation of out-of-specification (OOS) 

test results and how the laboratory interfaces with other units through the 

laboratory investigation process.

Why should you Attend:
All Laboratory and Quality Assurance management, analysts and reviewers 

should be aware of the FDA expectations for procedures that define a 

complete, scientifically sound investigation of each out-of-specification and 

out-of-trend laboratory observation and evidence that laboratory personnel 

are following the procedures.

Areas Covered in the Session:
Why the regulators are concerned about the handling of OOS investigations
The FDA model for handling OOS investigations
Commonly accepted terminology such as repeat testing and retesting
How the laboratory can meet regulatory expectations for OOS investigations
The interaction between the laboratory and other units in the organization

Who Will Benefit:
Laboratory Managers
Laboratory Supervisors
Laboratory Analysts
Quality Assurance Managers
Quality Assurance Record Reviewers

Speaker Profile:
John (Jerry) Lanese is an independent consultant with a focus on Quality 

Systems and the components of an effective Quality System. He received a 

BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from 

the University of Michigan and began his career teaching Analytical Chemistry 

in a small liberal arts college. Dr. Lanese moved from the academic 

environment to the pharmaceutical industry where he has managed Analytical 

Research, Quality Control and Quality Assurance functions.

Event Cost & Details:
One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

 


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