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:471981 DTSTAMP:20260504T183846Z SUMMARY:Aseptic Processing in the Manufacture of Biotech and Pharmaceu tical Products DESCRIPTION:Sterile products may be broadly classified into two main c ategories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and thos e that are aseptically sterilized, that is, filter sterilized as a bul k product, filled, and then sealed. Aseptic Processing play a critical role with large molecules that cannot be terminally sterilized. The v erification of the process to produce sterile product is evaluated thr ough the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the vo lumes filled over a defined period.\nAseptic Processing involves risk assessment on an on-going basis because of the inherent risks due to c onsequences of management and process failure and challenges within th e detection, isolation, control, and management of product contaminati on. Within aseptic processing, the severity of the consequences of a f ailure can be severe to the end user while detection through sterility testing remains rather limited because of the small number of final p roducts tested.\nThe FDA and EMA require that any product that may be terminally sterilized be managed in that fashion. However, almost all large molecules and some small molecules can only be sterilized by ase ptic processes, i.e., membrane filtration.\nWith membrane filtration, it is essential to establish acceptable levels of microbiological cont amination to ensure both product safety and compliance. Meeting steril ity claims for Phase 1, 2, 3 and commercial products in a timely and e ffective manner is important in avoiding costly delays. In addition, s ince aseptic processes are associated with endotoxin control, it too, must be managed to acceptable levels.\n\nLearning Objectives:\nSeminar participants will learn the following:\n\nGain an understanding of th e fundamental principles and skills necessary to conduct Aseptic Proce ssing of Sterile Drug Products with minimum risk\nAnalyze issues impac ting Aseptic Processing to include the environment, personnel, gowning and sanitization\nAcquire the skills necessary to control the process environment\nMinimize media fill failures to permit production throug hput\nDetermine how to develop media fill simulations to include the \ "worst case\" scenarios\nLearn best practice techniques for determinin g media fill sizes\n\nWho will Benefit:\n\nAseptic Processing\nManufac turing\nQuality Control\nQuality Assurance\nRegulatory Compliance\nMic robiology\nValidation\n\n\nFor more information visit https://medtechi q.ning.com/events/aseptic-processing-in-the-manufacture-of-biotech-and DTSTART;TZID=America/New_York:20220614T073000 DTEND;TZID=America/New_York:20220614T140000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/aseptic-processing-in-manufac ture-of-biotech-and-pharmaceutical-products-seminar-training-80667SEM- prdsm?channel=MedTech%20I.Q URL:https://www.complianceonline.com/aseptic-processing-in-manufacture -of-biotech-and-pharmaceutical-products-seminar-training-80667SEM-prds m?channel=MedTech%20I.Q CONTACT:8887172436 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/10395657469?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR