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DTSTART:19700308T020000
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UID:2140535:Event:70068
DTSTAMP:20260523T043926Z
SUMMARY:Webinar on FDA Compliance and Laboratory Computer System Valid
 ation
DESCRIPTION:Description :\nYou should attend this seminar if you are r
 esponsible for planning, executing or managing the validation of labor
 atory computer systems governed by FDA regulations.\nEffective and com
 pliant computer system validation is critical to any FDA-regulated org
 anization. During the past 30 years, best practices have been develope
 d that, if followed, can ensure laboratory computer systems are valida
 ted efficiently and in compliance with FDA regulations.\nThere is an e
 normous body of documentation and information available on computer sy
 stem validation, which can be overwhelming. This course will provide a
  condensed overview of the practices that deliver the best results by 
 directing the attendees to the most critical and cost-effective of met
 hods, techniques and tools available.\nAreas Covered in the Session :\
 nGain an understanding of laboratory system computer validation planni
 ng, execution and management concepts\nDiscuss the best practices for 
 laboratory computer system validation that will ensure compliant resul
 ts while minimizing costs\nIdentify the GAMP 5 category for the system
  to understand how best to approach validation, particularly testing\n
 Discuss the key documentation associated with validating laboratory sy
 stems and maintaining them in a validated state, while minimizing cost
 s\nLearn how to leverage these practices across all systems by creatin
 g a standardized program for FDA-regulated systems\nUnderstand the tra
 ining that must be provided to business and IT staff involved in the v
 alidation process\nDiscuss the business process re-engineering opportu
 nities that might be leveraged as a system is implemented, particularl
 y if it is more advanced than the legacy system in terms of technology
  and functionality\nLearn the advantage of incorporating a formal orga
 nizational change management system into the validation effort to ensu
 re that users fully embrace the new technology and functionality\nWho 
 Will Benefit:\nThis webinar is intended for those working in the FDA-r
 egulated industries, including pharmaceutical, medical device, biologi
 cal, animal health and tobacco.  Functions that are applicable includ
 e research and development, manufacturing, Quality Control, distributi
 on, clinical testing and management, adverse events management and pos
 t-marketing surveillance.\nProfessionals who will benefit include:\nIn
 formation Technology Analysts\nInformation Technology Developers and T
 esters\nQC/QA Managers and Analysts\nAnalytical Chemists\nCompliance a
 nd Audit Managers\nLaboratory Managers\nAutomation Analysts\nComputer 
 System Validation Specialists\nGMP Training Specialists\nBusiness Stak
 eholders/Subject Matter Experts\nBusiness System/Application Testers\n
 Consultants working in the life sciences industry who are involved in 
 computer system implementation, validation and compliance.\n\nFor more
  information visit https://medtechiq.ning.com/events/webinar-on-fda-co
 mpliance-and-laboratory-computer-system-2
DTSTART;TZID=America/New_York:20160727T130000
DTEND;TZID=America/New_York:20160727T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1828
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1828
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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