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DTSTART:19700308T020000
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UID:2140535:Event:79195
DTSTAMP:20260522T012211Z
SUMMARY:Best Practices to Support FDA Computer System Validation
DESCRIPTION:Overview:We will cover the importance of maintaining the d
 ocumentation from every computer system validation effort in a \"curre
 nt\" state. The system must be maintained in a validated state through
 out its entire life cycle, and the accompanying validation documentati
 on must also be maintained.\nWhy should you Attend:This session will a
 ddress the specific way of documenting your computer system validation
  work to ensure it meets FDA requirements and can pass an inspection. 
 There are specific requirements that must be followed in order for the
  Agency to consider the documentation valid, and without following the
 se, there is a great risk of invalidating work.\nAreas Covered in the 
 Session:21 CFR Part 11, Electronic Records/Electronic Signatures (ER/E
 S)Data Archival to ensure security, integrity and complianceLearn the 
 requirements for documenting efforts related to systems governed by FD
 ADiscuss the best practices for documenting computer system validation
  efforts, including requirements, design, development, testing and ope
 rational maintenance procedures\nWho Will Benefit:Information Technolo
 gy AnalystsInformation Technology Developers and TestersQC/QA Managers
  and AnalystsAnalytical ChemistsLaboratory ManagersAutomation Analysts
 \nSpeaker Profile: Carolyn (McKillop) Troiano has more than 35 years o
 f experience in the tobacco, pharmaceutical, medical device and other 
 FDA-regulated industries. She has worked directly, or on a consulting 
 basis, for many of the larger pharmaceutical and tobacco companies in 
 the US and Europe, developing and executing compliance strategies and 
 programs.\nEvent Fee: One Dial-in One Attendee Price: US $150.00\nCont
 act Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: 
 support@compliance4All.com\n\nFor more information visit https://medte
 chiq.ning.com/events/best-practices-to-support-fda-computer-system-val
 idation
DTSTART;TZID=America/New_York:20180807T100000
DTEND;TZID=America/New_York:20180807T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 2005LIVE?channel=medtechiq_Aug_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=502005
 LIVE?channel=medtechiq_Aug_2018_SEO
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016576?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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