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DTSTAMP:20260522T111025Z
SUMMARY:Efficient Computer System Validation - 10 Easy Steps
DESCRIPTION:Overview: This webinar details all of the templates used t
 o create validation documentation, usually saving two-thirds of the ti
 me and costs. The 10-step risk-based approach to COTS software validat
 ion minimized documentation and ensures efficient implementation of ne
 w and upgraded computer systems. This experience will prepare you to p
 erform a validation project. Areas Covered in the Session:\nLearn whi
 ch documents the FDA expects to audit.\nHow to use the risk-based vali
 dation approach to lower costs.\nHow to link requirements, specificati
 ons, risk management, and testing. \nDocument a computer system valid
 ation project using easy to understand fill-in-the-blank templates.\nB
 ased on: \"Risk-Based Software Validation - Ten Easy Steps\" (Davis Ho
 rwood International and PDA - www.pda.org, 2006). \nStep-by-step inst
 ructions for performing and documenting a risk assessment, and how to 
 use the results to reduce validation documentation. \nReduce testing 
 by writing test cases that trace to elements of risk management.\n\nWh
 o Will Benefit:\n\nIT\nQA\nQC\nLaboratory staff\nManagers\nGMP, GCP, G
 LP professionals\n\n\n\n\nDavid Nettleton, is an FDA Compliance Specia
 list for 21 CFR Part 11, HIPAA, and Computer System Validation. His la
 test book is \"Risk Based Software Validation - Ten easy Steps\" that 
 relates to the development, purchase, installation, operation and main
 tenance of computerized systems used in regulated applications. He spe
 cializes in performing gap analysis, remediation plans, SOP developmen
 t, vendor audits, training, and project management. He has completed m
 ore than 185 mission critical software validation projects.\n\nQuick C
 ontact:\nGlobalCompliancePanel USA Phone:800-447-9407webinars@globalco
 mpliancepanel.comhttp://www.globalcompliancepanel.comEvent Link - htt
 p://bit.ly/1g0k6k5\n\n\n\n\n\nFor more information visit https://medte
 chiq.ning.com/events/efficient-computer-system-validation-10-easy-step
 s
DTSTART;TZID=America/New_York:20140326T100000
DTEND;TZID=America/New_York:20140326T110000
CATEGORIES:webinar, pharma, medical, clinical, health
LOCATION:Online Event
WEBSITE:http://bit.ly/1g0k6k5
URL:http://bit.ly/1g0k6k5
CONTACT:8004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011838?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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