BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:470832
DTSTAMP:20260524T051024Z
SUMMARY:A risk based approach to GxP Compliant Laboratory Computerized
  Systems
DESCRIPTION:Laboratory Computerized Systems and data management operat
 ions are increasing in variety, sophistication and complexity in the G
 xP environment. Widespread reliance on these systems, along with their
  potential impact on data integrity, and the trend towards cost effici
 ency within companies, means that companies need achieve GxP complianc
 e of laboratory computerized systems– within a reasonable budget and
  timeline.\nThe wide diversity of these systems, coupled with their ca
 pability for networking, makes it impractical and inefficient to have 
 single approach to achieve GxP compliance for all systems. For example
 , a High Performance Liquid Chromatography (HPLC) with a Photo Diode A
 rray (PDA) detector is much more complex than a pH meter, and will req
 uire a correspondingly more detailed and complex implementation, contr
 ol and maintenance approach.\nPoor management of laboratory computeriz
 ed system acquisition, implementation and operation may result in:\n\n
 \nFailing to meet process and user requirements\nUnacceptable cost or 
 time overruns\nRisk of non-compliance\nData Integrity issues\n\n\n\nOn
  the other hand, there are major business benefits to both regulated o
 rganizations and suppliers, in delivering systems that defined and spe
 cified and are easier to support and maintain. Benefits include:\n\n\n
 Reduction of cost and time taken to achieve and maintain compliance\nE
 arly defect identification and resolution leading to reduced impact on
  cost and schedule\nCost effective operation and maintenance\n\n\n\nLe
 arning Objectives:\nThis hands-on seminar provides a practical, risk b
 ased approach to laboratory computerized system specification, verific
 ation, and implementation by:\n\nExamining the system life cycle and i
 ts applicability for most laboratory computerized systems\nIdentifying
  characteristics that distinguish various types of laboratory computer
 ized systems\nDeveloping a rationale for scaling activities and effort
  based upon risk, complexity, and novelty\nDefining a strategy for sup
 plier assessments, and the effective leveraging of supplier knowledge,
  experience, and documentation\nApplying the GAMP® 5 Quality Risk Man
 agement (QRM) approach\nDefining necessary operational and maintenance
  activities\nRecommending an approach to system retirement\nLeveraging
  deliverables and activities for very similar or identical systems\n\n
 \nWho will Benefit:\n\nLab Director\nLab Scientists\nComputer Validati
 on Professional responsible for defining and managing laboratory compu
 terized systems in regulated life science industries\nInformation Tech
 nology (IT) personnel\nIT support services\nManagement and Laboratory 
 System users\nSoftware Developers\nSuppliers of Computerized systems i
 ncluding suppliers or:\nSoftware\nHardware\n\n\n\n\nFor more informati
 on visit https://medtechiq.ning.com/events/a-risk-based-approach-to-gx
 p-compliant-laboratory-computerized
DTSTART;TZID=America/New_York:20220124T110000
DTEND;TZID=America/New_York:20220125T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/gxp-compliant-laboratory-comp
 uterized-systems-gamp-5-seminar-training-80516SEM-prdsm?channel=MedTec
 h%20I.Q
URL:https://www.complianceonline.com/gxp-compliant-laboratory-computer
 ized-systems-gamp-5-seminar-training-80516SEM-prdsm?channel=MedTech%20
 I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9832493092?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR