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:82265
DTSTAMP:20260524T100641Z
SUMMARY:Computer System Validation (CSV) for FDA-Regulated Computers
DESCRIPTION:Overview\nFDA requires that all computer systems used to p
 roduce, manage and report on GxP (GMP, GLC, GCP) related products be v
 alidated and maintained in accordance with specific rules. This webina
 r will leave you with the information needed to plan, execute and docu
 ment a computer system validation effort that meets FDA compliance sta
 ndards.\nYou'll learn about the various computer system validation del
 iverables and how to document them through the entire process. You wil
 l learn about what must be done to ensure the system remains in a vali
 dated state. In addition, you'll learn all about how to create and mai
 ntain good FDA-compliant documentation using a strategic approach base
 d on the System Development Life Cycle (SDLC) Methodology.\nWhy should
  you Attend\n This webinar will help you understand in detail Compute
 r System Validation (CSV) and how to apply the System Development Life
  Cycle (SDLC) Methodology when validating computer systems subject to 
 FDA regulations.\nThis is critical in order to develop the appropriate
  validation strategy and achieve the thoroughness required to prove th
 at a system does what it purports to do.\nIt also ensures that a syste
 m is maintained in a validated state throughout its entire life cycle,
  from conception through retirement. We will discuss the phases within
  the SDLC, and how these form the basis for any CSV project. The impor
 tance of the sequence of steps will also be covered.\nAreas Covered in
  the Session\n\nComputer System Validation (CSV)\nSystem Development L
 ife Cycle (SDLC) Methodology\nGood\"Variable\" Practice (GxP) (Good Ma
 nufacturing\nPractice (GMP), Good Laboratory Practice, Good Clinical P
 ractice (GCP)\nValidation Planning\nGAMP 5 System Classification\nRisk
  Assessment\nFunctional Requirements Specification\nConfiguration and 
 Custom Coded Solutions\nInstallation Qualification (IQ) Testing\nOpera
 tional Qualification (OQ) Testing\nPerformance Qualification (PQ) Test
 ing (User Acceptance Testing/UAT\nValidation Summary Report\nOperation
 al Maintenance for Validated Systems\nPolicies and Procedures\nTrainin
 g\nOrganizational Change Management (OCM)\nPeriodic System Review\nDis
 aster Recovery and Business Continuity Planning\nSystem Retirement\n\n
 Who Will Benefit\n\nInformation Technology (IT) Analysts\nIT Developer
 s\nIT Support Staff\nQC/QA Managers and Analysts\nClinical Data Manage
 rs and Scientists\nCompliance Managers and Auditors\nLab Managers and 
 Analysts\nComputer System Validation Specialists\nGMP Training Special
 ists\nBusiness Stakeholders using Computer Systems regulated by FDA\nR
 egulatory Affairs Personnel\nConsultants in the Life Sciences and Toba
 cco Industries\nInterns working at the companies listed above\nCollege
  students attending schools and studying computer system validation, r
 egulatory affairs/matters (related to FDA) or any other discipline tha
 t involves adherence to FDA regulatory requirements\n\nSpeaker Profile
 \n\nCarolyn (McKillop) Troiano has more than 35 years of experience i
 n the tobacco, pharmaceutical, medical device and other FDA-regulated 
 industries. She has worked directly, or on a consulting basis, for man
 y of the larger pharmaceutical and tobacco companies in the US and Eur
 ope, developing and executing compliance strategies and programs. Caro
 lyn is currently active in the Association of Information Technology P
 rofessionals (AITP), and Project Management Institute (PMI) chapters i
 n the Richmond, VA area. \n\n\nFor more information visit https://med
 techiq.ning.com/events/computer-system-validation-csv-for-fda-regulate
 d-computers
DTSTART;TZID=America/New_York:20190328T100000
DTEND;TZID=America/New_York:20190328T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.traininng.com/webinar/computer-system-validation-(c
 sv)-for-fda-regulated-computers-200639live?medtechiq.ning-Mar-Seo-2019
URL:http://www.traininng.com/webinar/computer-system-validation-(csv)-
 for-fda-regulated-computers-200639live?medtechiq.ning-Mar-Seo-2019
CONTACT:18004479407
ORGANIZER;CN="Joseph Wilcox":https://medtechiq.ning.com/profile/Joseph
 Wilcox
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/1223597505?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Joseph W
 ilcox":https://medtechiq.ning.com/profile/JosephWilcox
END:VEVENT
END:VCALENDAR