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:468187 DTSTAMP:20260909T214739Z SUMMARY:21 CFR Part 11 Compliance for SaaS/Cloud Applications DESCRIPTION:This highly interactive two-day course uses real life exam ples and explores proven techniques for reducing costs, usually by two -thirds, associated with implementing, and maintaining computer system s in regulated environments.\n\nIt details the requirements for Part 1 1 and Annex 11: SOPs, software product features, infrastructure qualif ication, and validation.\nThe instructor addresses the latest computer system industry standards for data security, data transfer, audit tra ils, electronic records and signatures, software validation, and compu ter system validation.\nUnderstand the specific requirements associate d with local and SaaS/cloud hosting solutions.\nNearly every computeri zed system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to de crease software implementation times and lower costs using a 10-step r isk-based approach to computer system validation.\nThe instructor revi ews recent FDA inspection trends and discusses how to streamline docum ent authoring, revision, review, and approval.\nParticipants will lear n how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).\nThis course benefits anyone that u ses computer systems to perform their job functions and is ideal for p rofessionals working in the health care, clinical trial, biopharmaceut ical, and medical device sectors. It is essential for software vendors , auditors, and quality staff involved in GxP applications.\n\nLearnin g Objectives:\n\nReduce costs, usually by two-thirds, for compliance w ith electronic records\nLearn how to use electronic records and electr onic signatures to maximize productivity\nUnderstand what is expected in Part 11 and Annex 11 inspections so you are prepared\nAvoid 483 and Warning Letters\nUnderstand the responsibilities and specific duties of your staff including IT and QA\nUnderstand your responsibilities an d liabilities when using SaaS/cloud\nLearn how to perform risk-based C omputer System Validation using fill-in-the-blank templates\nHow to se lect resources and manage validation projects\n\"Right size\" change c ontrol methods that allows quick and safe system evolution\nMinimize v alidation documentation to reduce costs without increasing regulatory or business risk\nLearn how to reduce testing time and write test case s that trace to elements of risk management\n\nWho will Benefit:\n\nGM P, GCP, GLP, regulatory professionals\nQA/QC\nIT\nAuditors\nManagers a nd directors\nSoftware vendors, SaaS hosting providers\n\n\nFor more i nformation visit https://medtechiq.ning.com/events/21-cfr-part-11-comp liance-for-saas-cloud-applications-1 DTSTART;TZID=America/New_York:20210323T080000 DTEND;TZID=America/New_York:20210324T140000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/21-cfr-part-11-compliance-for -saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=MedTe ch%20I.Q URL:https://www.complianceonline.com/21-cfr-part-11-compliance-for-saa s-cloud-applications-seminar-training-80202SEM-prdsm?channel=MedTech%2 0I.Q CONTACT:8887172436 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/8664025086?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR