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DTSTAMP:20260522T004615Z
SUMMARY:Webinar on Analytical Instrument Qualification According The N
 ew Revision of USP 1058
DESCRIPTION:Overview: The first version of USP <1058> has been releas
 ed in 2008. Since then it has evolved as the global standard for analy
 tical instrument qualification, despite of some deficiencies of the fi
 rst version.\nFor example, the industry had difficulties to apply the 
 chapter for systems comprising equipment hardware and computer systems
 . In addition, there have always been comments about not enough detail
 s for the four qualification phases. These deficiencies have been clar
 ified in the new revision with much more details on integrated systems
  but still some interpretation is required for compliant and efficient
  implementation. This webinar will discuss all details and give strate
 gies and case studies for easy implementation. Areas Covered in the S
 ession:\n\nScope and principles of the new revision.\nChanges to the e
 xisting chapter\nApproaches for risk based qualification\nThe 4Q Quali
 fication lifecycle approach: DQ, IQ, OQ, PQ\nPurpose and contents of q
 ualification phases: DQ, IQ, OQ, PQ\nDealing with three instrument cat
 egories A, B and C\nProcedures and validation deliverables for the thr
 ee categories\nThe importance of the quality agreement between users a
 nd suppliers\nIntegrating software validation and equipment qualificat
 ion\nIntegrating the USP 1058 revision with the GAMP Guide on Laborato
 ry Computerized Systems\nDealing with changes of software, firmware an
 d equipment hardware\nRecommendations for effective implementation of 
 the new revision\n\nFor Easy Implementation, Attendees Will Receive:\n
 \nAnalytical Instrument Qualification for <1058>\nAllocating Analytica
 l Instruments to USP <1058> categories\nProcedures and deliverables fo
 r USP <1058> categories\n\nWho Will Benefit:\n\nQC managers\nQA manage
 rs and personnel\nAnalysts and lab managers\nQA managers and personnel
 \nRegulatory affairs\nTraining departments\nDocumentation department\n
 Consultans\n\n\n\nSpeaker Profile:Ludwig Huber Ph.D., is the director
  and editor of Labcompliance the global online resource for validation
  and compliance. He is the author of the books \"Validation and Qualif
 ication in Analytical Laboratories\" and \"Validation of Computerized 
 Analytical and Networked Systems, Informa Healthcare\". He has given m
 ore than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Valid
 ation around the world. For more information, please visit Dr. Huberâ€
 ™s website www.ludwig-huber.com.\nContact Detail:\nNetZealous - Compli
 ance4All,161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Ph
 one: +1-800-447-9407 Email: support@compliance4All.comhttp://www.compl
 iance4all.com/Event Link : http://bit.ly/1L4WgHV\n\n\n\nFor more info
 rmation visit https://medtechiq.ning.com/events/webinar-on-analytical-
 instrument-qualification-according-the-new
DTSTART;TZID=America/New_York:20151105T100000
DTEND;TZID=America/New_York:20151105T111500
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1L4WgHV
URL:http://bit.ly/1L4WgHV
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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