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:66532
DTSTAMP:20260521T220149Z
SUMMARY:Webinar On Computer System Validation: Step-by-Step
DESCRIPTION:Description :\nThe validation of computer system has been 
 an FDA requirement since more than 20 years. Nevertheless companies ha
 ve problems with implementation. This is proven through many FDA warni
 ng letters related to software and computer system validation, especia
 lly in the last three years. Validation professionals know the princip
 les but have problems with implementation, especially with the develop
 ment of protocols. This seminar will give a good understanding of FDA 
 requirements for computer system validation and provide steps for cost
 -effective implementation.\nFor easy implementation, attendees will re
 ceive\nSOP: Validation of Commercial Off-the-Shelf Computer Systems\nS
 OP: Development and Maintenance of Test Scripts for Software and Compu
 ter Systems\nChecklist: Using computers in FDA regulated environments\
 nAreas Covered in the Session :\nUS FDA and EU requirements and enforc
 ement practices\nLearning from recent FDA 483's and warning letters\nS
 electing the right validation model: qualification vs. verification\nE
 ight fundamental steps for computer system validation\nStructure and e
 xample of a validation plan\nJustification and documentation of risk l
 evels\nExample qualification document for suppliers of commercial syst
 ems\nExamples for requirement and functional specifications?\nExample 
 for IQ protocols\nOQ test protocols: development, execution, approval 
 - examples\nDocumentation of ongoing performance\nValidation of existi
 ng systems\nStructure and example of a validation report\nStep-by-step
  case studies from laboratories and manufacturing for easy implementat
 ion\nWho Will Benefit:\nA must attend webinar for professionals in Pha
 rmaceutical and medical device industry, Manufacturers of pharmaceutic
 al ingredients and Contract manufacturers and laboratories. The teams 
 that will benefit the most are:\nIT managers and system administrators
 \nQA managers and personnel\nQC Lab managers and üersonnel\nValidatio
 n specialists\nRegulatory affairs\nTraining departments\nDocumentation
  department\nConsultants\n\nFor more information visit https://medtech
 iq.ning.com/events/webinar-on-computer-system-validation-step-by-step
DTSTART;TZID=America/New_York:20150820T130000
DTEND;TZID=America/New_York:20150820T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1457
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1457
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
END:VEVENT
END:VCALENDAR