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DTSTAMP:20260523T034321Z
SUMMARY:Best Practices to Help you Pass an FDA Computer System (Valida
 tion)
DESCRIPTION:Overview:This webinar will help you understand the FDA's c
 urrent thinking on computer systems that are validated and subject to 
 inspection and audit.\nAreas Covered in the Session:21 CFR Part 11, El
 ectronic Records/Electronic Signatures (ER/ES)Data Archival to ensure 
 security, integrity and complianceValidation Strategy that will take i
 nto account the system risk assessment and system categorization (GAMP
  V) processesRecent FDA findings for companies in regulated industries
 \nWho Will Benefit:Anyone who is involved in the development, testing,
  manufacturing, storage, handling and distribution of product must und
 erstand and conform to FDA requirements for data quality and integrity
 , and computer system validation (CSV)Finally, anyone who is acting as
  a consultant or contractor to a company in an FDA-regulated industry 
 should attend to ensure they are able to bring the most current knowle
 dge and expertise to their assignment\nSpeaker Profile:Carolyn (McKill
 op) Troiano has more than 35 years of experience in the tobacco, pharm
 aceutical, medical device and other FDA-regulated industries. She has 
 worked directly, or on a consulting basis, for many of the larger phar
 maceutical and tobacco companies in the US and Europe, developing and 
 executing compliance strategies and programs.\nEvent Fee: One Dial-in 
 One Attendee Price: US$290.00\nContact Detail:Compliance4All DBA NetZe
 alous,Phone: +1-800-447-9407Email: support@compliance4All.com\n\nFor m
 ore information visit https://medtechiq.ning.com/events/best-practices
 -to-help-you-pass-an-fda-computer-system-validation
DTSTART;TZID=America/New_York:20181207T090000
DTEND;TZID=America/New_York:20181207T120000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/control/w_product/~product_id=5
 02202LIVE?channel=medtechiq_Dec_2018_SEO
URL:https://www.compliance4all.com/control/w_product/~product_id=50220
 2LIVE?channel=medtechiq_Dec_2018_SEO
CONTACT:Event Manager
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/2562020374?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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