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DTSTAMP:20260521T180800Z
SUMMARY:Webinar On - Auditing for 21 CFR Part 11
DESCRIPTION:This seminar will discuss the basics of Part 11 requiremen
 ts and practical techniques for evaluation of the current compliance s
 tatus of a given organization.  You will hear about validation plans,
  user requirements, test plans, test reports, change controls, standar
 d operating procedures, data backup and business continuity. Case stud
 ies will be used to highlight common issues and potential solutions.\n
  \n21 CFR Part 11 provides the basic framework for computer systems u
 sed to generate records and data used for analysis and presentation. V
 alidated computerized systems are integral for producing accurate, rel
 iable and consistent data. For many small to mid-sized organizations, 
 meeting the regulatory requirements is a daunting task and Part 11 com
 pliance is a major focus for audits. In this seminar, we will simplify
  the Part 11 requirements and provide practical tips in assessing comp
 uterized systems that will have you ready for your next audit.\n \nAr
 eas Covered in the Session :\n\nPart 11 requirements by FDA\nValidatio
 n of computer systems - Validation Plans, Requirements, Specifications
 , and Test Reports\nRecommended SOPS\nChange control\nData backup and 
 business continuity\nCompliance Assessment\nPlanning, preparing and ex
 ecuting audits\nCommon audit findings and tips for a successful audit\
 n\n \nWho Will Benefit:\nThis webinar will provide valuable informati
 on to: \n\nAnyone selecting computer systems intended for FDA regulat
 ed environments\nInformation technology professionals responsible for 
 files or network locations \nQuality professionals who organize, docu
 ment and verify system compliance\nExecutives evaluating requirements 
 Part 11 compliant systems\n\n\nFor more information visit https://medt
 echiq.ning.com/events/webinar-on-auditing-for-21-cfr-part-11
DTSTART;TZID=America/New_York:20140206T130000
DTEND;TZID=America/New_York:20140206T140000
CATEGORIES:online, webinar
LOCATION:5939 Candlebrook Ct,  Mississauga, ON L5V 2V5,  Canada
WEBSITE:https://www.compliancetrainings.com
URL:https://www.compliancetrainings.com
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011031?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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