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UID:2140535:Event:74610
DTSTAMP:20260414T031112Z
SUMMARY:OOS, Out-Of-Specification Laboratory Results
DESCRIPTION:Overview:The objective of this webinar is to develop an un
 derstanding of how a compliant laboratory handles the investigation of
  out-of-specification (OOS) test results and how the laboratory interf
 aces with other units through the laboratory investigation process.\nW
 hy should you Attend:All Laboratory and Quality Assurance management, 
 analysts and reviewers should be aware of the FDA expectations for pro
 cedures 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.\nArea
 s Covered in the Session:Why the regulators are concerned about the ha
 ndling of OOS investigationsThe FDA model for handling OOS investigati
 onsCommonly accepted terminology such as repeat testing and retestingH
 ow the laboratory can meet regulatory expectations for OOS investigati
 onsThe interaction between the laboratory and other units in the organ
 ization\nWho Will Benefit:Laboratory ManagersLaboratory SupervisorsLab
 oratory AnalystsQuality Assurance ManagersQuality Assurance Record Rev
 iewers\nSpeaker Profile:John (Jerry) Lanese is an independent consulta
 nt 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 bega
 n his career teaching Analytical Chemistry in a small liberal arts col
 lege. Dr. Lanese moved from the academic environment to the pharmaceut
 ical industry where he has managed Analytical Research, Quality Contro
 l and Quality Assurance functions.\nEvent Cost & Details:One Dial-in O
 ne Attendee Price: US$150.00\nContact Detail:Compliance4All DBA NetZea
 lous,Phone: +1-800-447-9407Email: support@compliance4All.com\n\nFor mo
 re information visit https://medtechiq.ning.com/events/oos-out-of-spec
 ification-laboratory-results
DTSTART;TZID=America/New_York:20170912T100000
DTEND;TZID=America/New_York:20170912T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1443LIVE?channel=medtechiq_Sep_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501443
 LIVE?channel=medtechiq_Sep_2017_SEO
CONTACT:8004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562014750?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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