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:80089 DTSTAMP:20260414T001810Z SUMMARY:Webinar On \"Process Validation Requirements & Compliance Strategies\" DESCRIPTION:\nDescription :\nThis Process Validation Requirements webi nar will review process validation basics, with emphasis on looking be yond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.Why ?\nWhen used as intended, process valid ation can provide increased process reliability, improved yields, and reduced operating expenses.\n\n\n\n\n\nAreas Covered in the Session :\ n\nGlobal Harmonization Task Force requirements (includes FDA and ISO) \nInstallation Qualification (IQ)\nOperational Qualification (OQ)\nPer formance Qualification (PQ)\nDesign Qualification\nFacilities and util ities\nStrategies for achieving a robust and reliable process.\nTypica l process validation protocols.\n\n\n\n\n\n\nWho Will Benefit:\n\nRese arch & Development\nQuality Engineers and Auditors\nManufacturing Engi neers\nQuality Assurance & Quality Control Teams\nOperations Teams\nDo cument Control\nDevice Development Teams\nPersonnel involved in Verifi cation and Validation planning, execution and documentation for device s\n\n\n\n\n\n\nAbout Speaker:\nJosé Mora is a Principal Consultant an d Project Manager specializing in Manufacturing Engineering, Quality S ystems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled doc ument systems, startup operations, process development and quality sys tems, having lectured internationally and presented webinars on these subjects.For over 30 years he has worked in the life sciences in posit ions ranging from Senior Engineer and Project Manager to Vice-Presiden t, specializing in manufacturing, process development, tooling, and qu ality systems. His medical device experience includes surgical instrum ents, PTA & PTCA dilatation and guiding catheters, plastic surgery imp lants and tissue expanders, urology implants and devices for the treat ment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. Wh erever he has worked, Jose has a track record of introducing world-cla ss methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process va lidation to Global Harmonization Task Force standards, and similar app roaches. He has implemented various good manufacturing practices like JIT, kanban systems, visual workplace and lean manufacturing practices . Jose has also published a white paper on the application of lean man ufacturing methods to the creation and management of controlled docume nts and a template for strategic deployment.\n\n\n\n\n\n\nFor more inf ormation visit https://medtechiq.ning.com/events/webinar-on-process-va lidation-requirements-amp-compliance DTSTART;TZID=America/New_York:20180925T130000 DTEND;TZID=America/New_York:20180925T143000 CATEGORIES:online, "/", webinar LOCATION:Online WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP001 10 URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP00110 CONTACT:1-844-216-5230 ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562020319?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill er":https://medtechiq.ning.com/profile/SamMiller END:VEVENT END:VCALENDAR