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:76676 DTSTAMP:20260412T130150Z SUMMARY:21 CFR Part 11 Validation Checklist | Computer Systems Validat ion DESCRIPTION:\nCourse \"21 CFR Part 11 Compliance for Computer Systems Regulated by FDA\" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.\n \nOverview:\n \nThe Webinar will focus on the importan ce of ensuring that electronic record/electronic signature (ER/ES) cap ability built into FDA-regulated computer systems meets compliance wit h 21 CFR Part 11. This includes development of a company philosophy an d approach, and incorporating it into the overall computer system vali dation program and plans for individual systems that have this capabil ity.\nFDA's 21 CFR Part 11 was enacted in the late 1990s and implement ation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when u sing ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identificati on of users that ensures the person signing the record is the same per son whose credentials are being entered and verified by the system. Ru le for changing passwords must be rigorously adhered to and the passwo rds must be kept secure.\n\n \n Location: Boston, MA Date:  January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM\nVenue: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA\n \nPr ice:\n \nPrice: $1,295.00 (Seminar Fee for One Delegate)\nRegister no w and save $200. (Early Bird)\nUntil December 10, Early Bird Price: $ 1,295.00 From December 11 to January 23, Regular Price: $1,495.00\nR egister for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*\nRegister for 10 attendees   Price: $7,122.00 $12,950.00 Y ou Save: $5,828.00 (45%)*\n \n\nContact us today!\n \nNetZealous L LC DBA GlobalCompliancePanel\njohn.robinson@globalcompliancepanel.com  Â \nsupport@globalcompliancepanel.com \nToll free: +1-800-447-9407\n Phone: +1-510-584-9661\n Website: http://www.globalcompliancepanel.co m\n \nRegistration Link - http://www.globalcompliancepanel.com/contr ol/globalseminars/~product_id=901300SEMINAR?medtechiq-January-2018-SEO \n \nFollow us on LinkedIn: https://www.linkedin.com/company/globalco mpliancepanel/\nLike us our Facebook page: https://www.facebook.com/Tr ainingsAtGlobalCompliancePanel/\nFollow us on Twitter: https://twitter .com/GCPanel\n \n \n\nFor more information visit https://medtechiq.n ing.com/events/21-cfr-part-11-validation-checklist-computer-systems-va lidation DTSTART;TZID=America/New_York:20180125T090000 DTEND;TZID=America/New_York:20180126T180000 CATEGORIES:regulatory, and, compliance, seminars LOCATION:Boston, MA WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=901300SEMINAR?medtechiq-January-2018-SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=901300SEMINAR?medtechiq-January-2018-SEO CONTACT:800-447-9407 ORGANIZER:NetZealous DBA as GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562015704?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR