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:62071 DTSTAMP:20260416T163505Z SUMMARY:Designing Effective and Efficient Extractables or Leachables S tudies for Biologics DESCRIPTION:Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.\n\nWhy Should You Attend:\nThe FDA ind ustry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components fo r extractable leachable for all injectibles. Since biologics products are particularly sensitive to leachable there has been increased scrut iny of extractable and leachable associated with biotechnology drug pr oducts. The time and resources required for testing for extractable/le achable can be conserved by appropriately planning the study.\nThis in teractive webinar will provide an overview of the steps in a typical E xtractables/Leachables study. The literature sources which can prelimi nary information essential for the plan of a E/L study will be discuss ed. Gap analysis of such literature leading to the design of an effici ent E/L study will be addressed. Steps in an E/L study, handling the d ata and cases studies will be presented.Practical difficulties encount ered by sponsors will be addressed.\nAreas Covered in the Seminar:\n\n Why test for Extractables Leachables.\nChallenges presented by E/L stu dies for Biologics.\nSources of E/L information and how to leverage th em.\nTesting for Extractables.\nTesting for Leachables.\nInterpretatio n of the E/L data.\n\nWho Will Benefit:\n\nR&D Laboratory personnel\nR &D Laboratory Supervisors and Management\nQC Laboratory personnel and management\nProtein Formulation Group personnel and Management\nRegula tory Affairs personnel\nRegulatory Affairs Management\nQC Laboratory p ersonnel and management\n\n\nInstructor Profile:\nDr. Subbarao, recei ved her Ph.D. in Bio-organic Chemistry from the Indian Institute of Te chnology, Bombay, India. Her hands-on industrial experience covers sta bility and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical metho ds and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases.\nShe i s an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as we ll as upgrade of existing Quality Systems for products during developm ent and in commercial phase.\nShe is currently a Senior Consultant wit h the Biologics Consulting Group specializing in Analytical, Stability , CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Fo cus Group Steering Committee. She also serves on the AAPS National Bio technology Conference Programming Committee for 2009 to 2011 as the Re gulatory Sciences lead.\n\nFor more information visit https://medtechi q.ning.com/events/designing-effective-and-efficient-extractables-or-le achables DTSTART;TZID=America/New_York:20130912T100000 DTEND;TZID=America/New_York:20130912T113000 CATEGORIES:webinar LOCATION:Online Event WEBSITE: URL: CONTACT:16506203915 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562006613?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR