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:65731 DTSTAMP:20260520T042554Z SUMMARY:Webinar Ensuring Data Integrity for FDA/EU Compliance DESCRIPTION:Description :\nFDA has found and reported about multiple c ases where companies manipulated electronic records.  Since then FDA inspectors have focused inspections on security, availability, accurac y and integrity of 'complete' records. FDA has trained inspectors to i dentify data falsification and recommended the same to industry QA dep artments and auditors. Just in the last three years FDA issued over 30 warning letters and 483 form inspectional observations related to ele ctronic records. The industry is unsure how to comply with FDA inspect ion requirements. Because of missing clear guidance from the FDA the i ndustry has lots of questions. Using recent warning letters as example s, this seminar will demonstrate how current data integrity requiremen ts will be identified, implemented and documented.\nFor easy implement ation, attendees will receive\nSOP: Integrity and Security of Electron ic Records\nSOP: Review of Electronic Audit Trail\nChecklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance\nArea s Covered in the Session :\nEight key FDA/EU requirements for integrit y and security of electronic records\nHow FDA inspectors check integri ty of data\nMost frequent data integrity issues: going through recent 483's, EIRs and warning letters\nThe importance of limited access to ' individual users' rather than to groups\nFDA compliant definition, acq uisition, maintenance and archiving of raw data\nCritical integrity an d security issues during the entire life of records\nExamples how to e nsure and document data integrity\nDocumenting changes of regulated da ta: paper, hybrid systems, electronic\nThe importance of electronic au dit trail to document data integrity\nReview of electronic audit trail : who, what, when and how\nEnsuring timely availability of data throug h validated back-up and archiving\nRequired skills and responsibilitie s of internal and 3rd party consultants?\nGoing through representative case studies: FDA observations, complete responses to each observatio n, corrective actions and preventive actions\nWho Will Benefit:\nEvery body using computers in FDA regulated environments\nIT managers and st aff\nManufacturers of drug substances (APIs)\nMedical Device Manufactu rers\nAnalytical Contract laboratories\nClinical contract laboratorier s\nQA managers and personnel\nQuality control directors or delegates\n Internal auditors\nRegulatory affairs\nTraining departments\nConsultan ts\nValidation specialists\nPrice tags:\nLive\nSingle Live : For One P articipant\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 899\nR ecording\nSingle REC : For One Participant - Unlimited Access for 6 Mo nths\n$ 299\nFor more information and enquiries contact us at\nComplia nce Trainings\n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada   Customer Support : #416-915-4458  Email : support@compliancetraini ngs.com\nFor more information about this event please visit\nhttps://c ompliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1455\n\ nFor more information visit https://medtechiq.ning.com/events/webinar- ensuring-data-integrity-for-fda-eu-compliance DTSTART;TZID=America/New_York:20150520T130000 DTEND;TZID=America/New_York:20150520T141500 CATEGORIES:webinar LOCATION:Canada WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a spx?id=FDB1455 URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx? id=FDB1455 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