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:67332 DTSTAMP:20260426T111048Z SUMMARY:Seminar on Validation and Part 11 Compliance of Computer Syste ms and Data at Sydney, Australia DESCRIPTION:Overview:\nAnalytical equipment should be qualified and co mputer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/P ICS GMP Annex 11 requirements to ensure data integrity, security and a vailability. Recent EU and FDA inspection documents prove that qualifi cation, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laborato ries also demonstrates that they struggle with either understanding or implementing the regulations.\nThis 2-day course provides the regulat ory background and guides attendees through the complete equipment qua lification, calibration and computer system validation processes from planning to report. It also helps to fully understand Part 11 and Anne x 11 requirements to ensure and document integrity and other requireme nts for electronic records and signatures.\nThe 2-day course not only ensures a full understanding of the regulations and guidelines for equ ipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispers ed into and between the presentations. About 50% of the total time wil l be dedicated to practical sessions. Here attendees work in small gro ups on case studies and prepare the answers using prepared fill-in tem plates. After the course a large variety of tools such as SOPs, valida tion examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.\nAdditional Bonus Material for easy implementation:\n70-p age primer Analytical Instrument Qualification and System Validation ( authored by Dr. Ludwig Huber)10 SOPs related to validation and qualifi cation of analytical equipment and computer systems. change control, r isk assessment, maintenance, security and integrity of electronic reco rdsFull Set of Qualification examples for an HPLC system Full set of V alidation examples of a chromatographic Data System\nWhy should you at tend?\nLearn about the regulatory background and requirements for equi pment qualification according to USP <1058>, computer system validatio n according to GAMP GuidesLearn how to ensure and document integrity o f raw data and other records according to Part 11 and Annex 11Be able to explain the difference between equipment calibration, qualification and system validationUnderstand and Implement the new UK MHRA GMP Dat a Integrity GuidelineLearn which equipment/systems need to be qualifie d or validatedBe able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordinglyUnderstand the logic and principles of instrumen t qualification and system validation from planning to reporting\nLoca tion: Sydney, Australia Date: December 10th and 11th, 2015 Time: 9 AM to 6 PM\n\nVenue: Hilton Sydney\nAddress: 488 George Street, Sydney, A ustralia 2000\n\nPrice: $1,695.00 (Without stay)\nRegister now and sav e $200.\nUntil November 15, Early Bird Price: $1,695.00\nFrom November 16 to December 08, Regular Price: $1,895.00\n\nPrice: $2,095.00 (With stay)\nRegister now and save $200.\nUntil November 15, Early Bird Pri ce: $2,095.00\nFrom November 16 to December 08, Regular Price: $2,295. 00\n\nRegistration Details:\nNetZealous LLC - DBA GlobalCompliancePane l\n161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA\nUSA Phon e: 1-800-447-9407\nFax: 302-288-6884\nsupport@globalcompliancepanel.co m\nhttp://www.globalcompliancepanel.com\nRegistration Link - http://bi t.ly/1RyDJCh\n\nFor more information visit https://medtechiq.ning.com/ events/seminar-on-validation-and-part-11-compliance-of-computer-system -2 DTSTART;TZID=America/New_York:20151210T090000 DTEND;TZID=America/New_York:20151211T180000 CATEGORIES:seminar LOCATION:Hilton Sydney, 488 George Street, Sydney, Australia 2000 WEBSITE:http://bit.ly/1RyDJCh URL:http://bit.ly/1RyDJCh CONTACT:18004479407 ORGANIZER:NetZealous LLC, DBA GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562013310?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR