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Fast Facts

Out-of-Specification Investigations – Beyond the laboratory

Mar 18,2010 - Mar 18,2010
Online Event, Palo Alto, California, United States
 

Highlights

This Out-of-Specification Investigations webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization.
Why Should You Attend :
Although the Barr Decision of the early 1990s surfaced the concern about out-of-specification results and investigations, many organizations have not determined how to effectively address the issue. Out-of-specification results bring out many reactions in the pharmaceutical firm: .emotional, political, finger pointing, denial. There inhibit a productive investigation and a timely conclusion of the investigation.

There is still confusion in the pharmaceutical firm as to how to handle that is demonstrated to be out-of-specification.

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.
The webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization.
The involvement of QA, Production, Packaging, Materials Management and Quality Control will be discussed.

Note:Discount available for 10% Please Contact us on (+1-650-620-3915 begin_of_the_skype_highlighting              +1-650-620-3915      end_of_the_skype_highlighting).











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Event Profile

Sponsors: ComplianceOnline
Speakers: John G. (Jerry) Lanese
Attendees: Personnel responsible for investigations, CAPA and Change Control,Quality Control analysts,Quality Control record reviewers,Quality Control Supervisors,Quality Control Managers,Quality Assurance record reviewers,Quality Assurance Supervisors

Contact Details

Contact person: Admin
Event website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701587?channel=gtm
Phone: 650-620-3915
Fax: 650-963-2556

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