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DTSTART:19700308T020000
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UID:2140535:Event:70074
DTSTAMP:20260515T160318Z
SUMMARY:Webinar on Data Governance for Computer Systems Regulated by F
 DA
DESCRIPTION:We will discuss the importance of establishing a data gove
 rnance framework and program for data that is collected, analyzed, sto
 red or reported using a computer system subject to FDA regulations. A 
 data governance framework is a logical structure for classifying, orga
 nizing and communicating complex activities involved in making decisio
 ns about and taking action on enterprise data. As data governed by FDA
  must adhere to the principles of Computer System Validation (CSV), Sy
 stem Development Life Cycle (SDLC) Methodology, and Electronic Records
  and Signatures (21 CFR Part 11), as applicable, we will look at ways 
 to leverage these in developing an overall data governance framework a
 nd program.\nAreas Covered in the Session :\nLinking data governance a
 ctivities and investments to corporate drivers, strategies and complia
 nce\nEstablish data governance program objectives, decision-making org
 anizational structures and assigned roles and responsibilities that fi
 t within the organizational culture\nUnderstand the role of data owner
 s vs. data stewards\nUnderstand the criticality of data identity, trus
 t, security, integrity, accessibility, reliability and consistency\nDe
 signing data governance processes that encompass people, processes and
  technology\nUnderstand the policies and procedures necessary to suppo
 rt the data governance framework\nWho Will Benefit:\nThis webinar is i
 ntended for those working in the FDA-regulated industries, including p
 harmaceutical, medical device, biological, animal health and tobacco. 
 Functions that are applicable include research and development, manufa
 cturing, Quality Control, distribution, clinical testing and managemen
 t, adverse events management and post-marketing surveillance.\nYou sho
 uld attend this webinar if you are responsible for planning, executing
  or managing the implementation of any system governed by FDA regulati
 ons, or if you are maintaining or supporting such a system. Examples o
 f who will benefit from this webinar include:\nInformation Technology 
 Analysts\nInformation Technology Developers and Testers\nQC/QA Manager
 s and Analysts\nAnalytical Chemists\nCompliance and Audit Managers\nLa
 boratory Managers\nAutomation Analysts\nComputer System Validation Spe
 cialists\nGMP Training Specialists\nBusiness Stakeholders/Subject Matt
 er Experts\nBusiness System/Application Testers\nThis webinar will als
 o benefit any consultants working in the life sciences industry who ar
 e involved in computer system implementation, validation and complianc
 e.\n\nFor more information visit https://medtechiq.ning.com/events/web
 inar-on-data-governance-for-computer-systems-regulated-by-fda
DTSTART;TZID=America/New_York:20160715T130000
DTEND;TZID=America/New_York:20160715T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1829
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1829
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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