OOS, Out-Of-Specification Laboratory Results
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Website http://www.compliance4all.com/control/w_product/~product_id=501443LIVE?channel=ourglocal_Sep_2017_SE |
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Category OOS Results, FDA Laboratory Operations, Quality Assurance, Laboratory Analysts Courses, Supervisors checklists, OOS investigations, Quality Assurance functions, laboratory management systems, 2017 laboratory Programs, Online Medical Programs
Deadline: September 12, 2017 | Date: September 13, 2017
Venue/Country: Fremont, U.S.A
Updated: 2017-07-17 15:59:55 (GMT+9)
Call For Papers - CFP
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 investigationsThe FDA model for handling OOS investigationsCommonly accepted terminology such as repeat testing and retestingHow the laboratory can meet regulatory expectations for OOS investigationsThe interaction between the laboratory and other units in the organizationWho Will Benefit:Laboratory ManagersLaboratory SupervisorsLaboratory AnalystsQuality Assurance ManagersQuality Assurance Record ReviewersSpeaker 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$150.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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