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:74900 DTSTAMP:20260519T044423Z SUMMARY:21 CFR Part 11 compliance for software validation and SaaS/Clo ud 2017 DESCRIPTION: \nCourse \"21 CFR Part 11 compliance for software valida tion and SaaS/Cloud\" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon fu ll completion.\n \nOverview:\n \n\nThis interactive two-day course e xplores proven techniques for reducing costs associated with implement ing, using, and maintaining computer systems in regulated environments .\nMany companies are outsourcing IT resources and getting involved wi th Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure complianc e for both infrastructure qualification and computer system validation . It is the regulated company that wants to avoid FDA form 483s and wa rning letters. The seminar is intended for regulated companies, softwa re vendors, and SaaS/Cloud providers.\nThe instructor addresses the la test computer system industry standards for data security, data transf er, audit trails, electronic records and signatures, software validati on, and computer system validation.\nToday the FDA performs both GxP a nd Part 11 inspections, the Europeans have released an updated Annex 1 1 regulation that expands Part 11 requirements and companies must upda te their systems and processes to maintain compliance.\nThis seminar w ill help you understand the specific requirements associated with loca l and SaaS/cloud hosting solutions.\nNearly every computerized system used in laboratory, clinical, manufacturing settings and in the qualit y process has to be validated.\nParticipants learn how to decrease sof tware implementation times and lower costs using a 10-step risk-based approach to computer system validation.\nFinally, the instructor revie ws recent FDA inspection trends and discusses how to streamline docume nt authoring, revision, review, and approval.\nThis course benefits an yone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the he alth care, clinical trial, biopharmaceutical, and medical device secto rs. It is essential for software vendors, auditors, and quality staff involved in GxP applications.\n\n\n \nContact us today!\n \nNetZealo us LLC DBA GlobalCompliancePanel\njohn.robinson@globalcompliancepanel. com  \nsupport@globalcompliancepanel.com \nToll free: +1-800-447-94 07\nPhone: +1-510-584-9661\n Website: http://www.globalcompliancepane l.com\n \nRegistration Link - http://www.globalcompliancepanel.com/co ntrol/globalseminars/~product_id=900924SEMINAR?medtechiq-October-2017- SEO\n \nFollow us on LinkedIn: https://www.linkedin.com/company/globa lcompliancepanel/\nLike us our Facebook page: https://www.facebook.com /TrainingsAtGlobalCompliancePanel/\nFollow us on Twitter: https://twit ter.com/GCPanel\n \n \n\nFor more information visit https://medtechi q.ning.com/events/21-cfr-part-11-compliance-for-software-validation-an d-saas-cloud DTSTART;TZID=America/New_York:20171012T083000 DTEND;TZID=America/New_York:20171013T170000 CATEGORIES:online, healthcare, training, courses LOCATION:Zurich, Switzerland WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=900924SEMINAR?medtechiq-October-2017-SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=900924SEMINAR?medtechiq-October-2017-SEO CONTACT:800-447-9407 ORGANIZER:NetZealous DBA as GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562015558?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR