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UID:1904@azbio.org
DTSTART;TZID=America/Phoenix:20240730T110000
DTEND;TZID=America/Phoenix:20240730T123000
DTSTAMP:20240712T154406Z
URL:https://www.azbio.org/events/fda-webinarenvironmental-monitoring-in-co
 mpounding
SUMMARY:FDA Webinar: Environmental Monitoring in Compounding -  - 30 Jul 24
  11:00
DESCRIPTION:\nDate: July 30\, 2024\nTime: 2:00 PM - 3:30 PM ET (11 AM - 12:
 30 PM AZ/PDT)\nLearn More and Register\n\nABOUT THIS WEBINAR (Hosted by CD
 ER SBIA)\n\nAttendees will hear an overview of Environmental Monitoring fo
 r compounding facilities and the role environmental monitoring plays in en
 suring product quality and patient safety. Presenters will discuss the sta
 tutory and regulatory requirements for environmental monitoring. FDA also 
 will describe the agency’s expectations for compounding pharmacies (unde
 r section 503A) and outsourcing facilities (under section 503B) for enviro
 nmental monitoring. Finally\, FDA will discuss different methods specific 
 to environmental monitoring.\n\nINTENDED AUDIENCE\n\n 	Outsourcing facilit
 ies\n 	Compounding pharmacies\n 	State pharmacy regulators\n 	Consultants 
 who work with outsourcing facilities and compounding pharmacies\n\nTOPICS\
 n\n 	What is environmental monitoring and why is it important in compoundi
 ng quality and patient safety?\n 	How environmental monitoring is used to 
 assess the dynamic conditions of the production area and identify potentia
 l routes of contamination\n 	Statutory requirements for compounding pharma
 cies (503A) and outsourcing facilities (503B)\n 	Regulatory requirements a
 nd the agency’s expectations\n 	Techniques and methods specific to envir
 onmental monitoring\n 	Key concepts related to design and implementation o
 f environmental and personnel monitoring programs\n\nLEARNING OBJECTIVES\n
 Define environmental monitoring and its significance in ensuring product q
 uality and patient safety\nDescribe statutory requirements for compounding
  pharmacies (503A) and outsourcing facilities (503B)\nExplain regulatory r
 equirements and the agency’s expectations\nIdentify types of monitoring 
 specific to environmental monitoring\nRecognize concepts related to design
  and implementation of environmental and personnel monitoring programs\n\n
 SPEAKERS\nDoan-Trang Vuong\, MS\nConsumer Safety Officer\nDivision of Comp
 ounding I\nOffice of Compounding Quality and Compliance (OCQC)\nCenter for
  Drug Evaluation and Research (CDER) | US FDA\n\nCDR Brandon C. Heitmeier\
 , MPH\, CPH\, CPGP\nConsumer Safety Officer\nDivision of Compounding I\nOC
 QC | OC | CDER | FDA
CATEGORIES:Conventions and National Events
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