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:66726 DTSTAMP:20260520T113429Z SUMMARY:Seminar on Verification vs. Validation - Product Process Softw are and QMS at Las Vegas, NV DESCRIPTION:Overview:\nThis course will review the company Master Vali dation Plan for major key inputs and CGMP deficiencies. It will addres s the FDA's newer & tougher regulatory stance. This course's aim is to prove \"Product Risk Based V&V\" by sufficient, targeted and document ed risk-based V&V test case elements/scripts. It will teach participan ts to evaluate its elements against ISO 14971 and ICH Q9 for hazard an alysis and product risk management.\n\nAgenda:\n \nDay 1 Schedule:\n  \nLecture 1:\nMaster Validation Planning and the Master Validation Pl an(s)\nLecture 2:\nProduct, Process / Equipment Hardware V&V\nLecture 3:\nProduct / Device V&V\nLecture 4:\nSoftware V&V\nLecture 5:\nQualit y Management System / 21 CFR Part 11 V&V\nLecture 6:\nSummary of morni ng discussion\nLecture 7:\nGroup activity on the MVPs\nLecture 8:\nRev iew of group activity and Q&A\n \nDay 2 Schedule:\n \nLecture 1:\nSo ftware V&V documentation \"model\"\nLecture 2:\nSoftware V&V protocols - \"black box\", \"white box\"\nLecture 3:\nElectronic Records and El ectronic Signatures (Part 11)\nLecture 4:\nSummary of morning discussi on\nLecture 5:\nGroup activity on 1) hardware / equipment, and 2) soft ware V&V protocols\nLecture 6:\nReview of group activity and Q&A\nLect ure 7:\nCourse summary discussion\nLecture 8:\nSummary of morning disc ussion\nLecture 9:\nGroup activity on the MVPs\nLecture 10:\nReview of group activity and Q&A\n \nSpeaker\nJohn E Lincoln is Principal of J . E. Lincoln and Associates LLC, a consulting company. John, a graduat e of UCLA, is a medical device and Regulatory Affairs consultant. \nV enue: Hilton Grand Vacations Suites at the Flamingo\nHotel: Hilton Gra nd Vacations Suites at the Flamingo   3575 Las Vegas Boulevard South , Las Vegas, Nevada, 89109-4313, USA\nDate: October 15th & 16th, 2015\ nTime: 9:00 AM to 6:00 PM\nPrice: $1,695.00 (Seminar for One Delegate) \nRegister now and save $200. (Early Bird) Until August 31, Early Bird Price: $1,695.00 From September 01 to October 13, Regular Price: $1,8 95.00\nContact Information:\nNetZealous LLC,\nDBA GlobalCompliancePane l\n161 Mission Falls Lane,\nSuite 216, Fremont, CA 94539, USA      Â Â Â Â \nUSA Phone: 800-447-9407\nFax: 302-288-6884\nsupport@globalc ompliancepanel.com  \nhttp://www.globalcompliancepanel.com\nEvent Reg istration Link: https://goo.gl/Rxmg70\n \n\nFor more information visi t https://medtechiq.ning.com/events/seminar-on-verification-vs-validat ion-product-process-software DTSTART;TZID=America/New_York:20151015T090000 DTEND;TZID=America/New_York:20151016T180000 CATEGORIES:seminar LOCATION:Hilton Grand Vacations Suites at the Flamingo WEBSITE:https://goo.gl/Rxmg70 URL:https://goo.gl/Rxmg70 CONTACT:18004479407 ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo binson ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562012375?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR