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:72500 DTSTAMP:20260520T065642Z SUMMARY:Ten-Step Process for COTS Risk-Based Computer System Validatio n 2017 DESCRIPTION:Course \"21 CFR Part 11 compliance for software validation and SaaS/Cloud\" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full compl etion. Overview: •    This interactive two-day course explores p roven techniques for reducing costs associated with implementing, usin g, and maintaining computer systems in regulated environments. •    Many 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. •    The instructor address es the latest computer system industry standards for data security, da ta transfer, audit trails, electronic records and signatures, software validation, and computer system validation. •    Today the FDA p erforms both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and c ompanies must update their systems and processes to maintain complianc e. •    This seminar will help you understand the specific requir ements associated with local and SaaS/cloud hosting solutions. •    Nearly every computerized system used in laboratory, clinical, manu facturing settings and in the quality process has to be validated. •     Participants learn how to decrease software implementation time s and lower costs using a 10-step risk-based approach to computer syst em validation. •    Finally, the instructor reviews recent FDA in spection trends and discusses how to streamline document authoring, re vision, review, and approval. •    This course benefits anyone th at uses computer systems to perform their job functions and is ideal f or regulatory, clinical, and IT professionals working in the health ca re, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involve d in GxP applications.\n\nFor More Information- https://www.globalcomp liancepanel.com/control/sponsorship   Contact us today! NetZealous LL C DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com    support@globalcompliancepanel.com   Toll free: +1-800-447-9407 Pho ne: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Reg istration Link –http://www.globalcompliancepanel.com/control/globals eminars/~product_id=900926SEMINAR?medtechiq-July-2017-SEO Follow us on LinkedIn:https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompl iancePanel/ Follow us on Twitter: https://twitter.com/GCPanel\n\nFor m ore information visit https://medtechiq.ning.com/events/ten-step-proce ss-for-cots-risk-based-computer-system-validation DTSTART;TZID=America/New_York:20170706T090000 DTEND;TZID=America/New_York:20170707T180000 CATEGORIES:online, healthcare, training, courses LOCATION:Washington, DC WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=900926SEMINAR?medtechiq-July-2017-SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=900926SEMINAR?medtechiq-July-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/2562032188?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR