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:67704 DTSTAMP:20260904T190051Z SUMMARY:Seminar on Modern Approaches to Process Validation: Requiremen ts for Process Design, Design of Facilities and the Qualification of E quipment and Utilities at Mumbai DESCRIPTION:Overview:\nCompanies face many common issues and confusion when creating or revamping their validation programs. Some of these c ommon issues are:\n\nCompany has expertise in its process validation p rogram but can never quite get is arms around the facility and equipme nt changes that require never ending equipment qualification (IQ, OQ, PQ),\nCustomer or 483 audit findings require the company to deviate fr om its own validation program to meet the needs of the FDA or the cust omer\nFor systems that employ software and hardware, how does the comp any manage the validation activities (i.e. through the software valida tion effort or through the equipment qualification program? \n\nWhy s hould you attend?\nAttend this FDA validation seminar to get deep know ledge about:\n\nHow to define a Sustainable Structure of a Firm's Vali dation Program\nUnderstand How Change Control and Other Quality Progra ms Feed Into the Validation Program\nOffer Usable Protocol and Other V alidation Program Document Templates\nDefine Minimal Recommended Tests and Verifications for\nEquipment Qualification\nProcess Validation\nS oftware Validation\n\n\n\nAreas Covered in the Session:\n\nBasics Of V alidation\nThe Components of a Sustainable Validation Program\nOther P rograms that Feed the Validation Program (1 Hour)\nEquipment, Utility, and Facility Qualification\nProcess Validation\nSoftware Validation\n Time and Costs of Validation\nResponding to Validation and Other Relat ed Audit Findings\n\nWho Will Benefit:\n\nInternal Auditors\nRegulator s\nLegal Departments\nCompliance Officers\nValidation Managers\nQC Man agers\nQA Managers\nFacilities and Engineering Department Staff\n\nSpe aker:\nDavid R. Dills\nRegulatory Affairs & Compliance Consultant, \n David R. Dills Regulatory Affairs & Compliance Consultant currently p rovides regulatory affairs, compliance and quality consultative servic es for early-stage and established Class I/II/III device, In Vitro Dia gnostics, and bio/pharmaceutical manufacturers on the global landscape , and also has an accomplished record with more than 25 years of exper ience in the areas of Regulatory Affairs, Compliance and Quality Syste ms. \nDate: February 4th and 5th, 2016                 Â Â Â  Time: 9 AM to 6 PM\nVenue: The LaLiT Mumbai \nVenue Address: The LaLiT Mumbai,\nSahar Airport Road, Andheri East, Mumbai, Maharash tra – 400059\nPrice: ₹ 14,000\nRegister now and save 2000 (Early B ird)\nUntil January 10, Early Bird Price: 14,000 from January 11 to Fe bruary 02, Regular Price: 16,000\n \nContact Address:\nNetZealous DBA GlobalCompliancePanel\n \nPhone: 080-325-28001\nFax: 080-25149544 \ nEmail: customersupport@globalcompliancepanel.com\nWebsite: http://www .globalcompliancepanel.in\nRegistration Links - http://bit.ly/Modern-A pproaches-to-Process-Validation\n\nFor more information visit https:// medtechiq.ning.com/events/seminar-on-modern-approaches-to-process-vali dation-requirements-1 DTSTART;TZID=America/New_York:20160204T090000 DTEND;TZID=America/New_York:20160205T180000 CATEGORIES:seminar, pharma, medical, process, validation LOCATION:The LaLiT Mumbai WEBSITE:https://www.globalcompliancepanel.in URL:https://www.globalcompliancepanel.in CONTACT:080-325-28001 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/2562011438?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR