Date/Time
Date(s) - 30 Jul 2024
11:00 AM - 12:30 PM
Date: July 30, 2024
Time: 2:00 PM – 3:30 PM ET (11 AM – 12:30 PM AZ/PDT)
Learn More and Register
ABOUT THIS WEBINAR (Hosted by CDER SBIA)
Attendees will hear an overview of Environmental Monitoring for compounding facilities and the role environmental monitoring plays in ensuring product quality and patient safety. Presenters will discuss the statutory and regulatory requirements for environmental monitoring. FDA also will describe the agency’s expectations for compounding pharmacies (under section 503A) and outsourcing facilities (under section 503B) for environmental monitoring. Finally, FDA will discuss different methods specific to environmental monitoring.
INTENDED AUDIENCE
- Outsourcing facilities
- Compounding pharmacies
- State pharmacy regulators
- Consultants who work with outsourcing facilities and compounding pharmacies
TOPICS
- What is environmental monitoring and why is it important in compounding quality and patient safety?
- How environmental monitoring is used to assess the dynamic conditions of the production area and identify potential routes of contamination
- Statutory requirements for compounding pharmacies (503A) and outsourcing facilities (503B)
- Regulatory requirements and the agency’s expectations
- Techniques and methods specific to environmental monitoring
- Key concepts related to design and implementation of environmental and personnel monitoring programs
LEARNING OBJECTIVES
Define environmental monitoring and its significance in ensuring product quality and patient safety
Describe statutory requirements for compounding pharmacies (503A) and outsourcing facilities (503B)
Explain regulatory requirements and the agency’s expectations
Identify types of monitoring specific to environmental monitoring
Recognize concepts related to design and implementation of environmental and personnel monitoring programs
SPEAKERS
Doan-Trang Vuong, MS
Consumer Safety Officer
Division of Compounding I
Office of Compounding Quality and Compliance (OCQC)
Center for Drug Evaluation and Research (CDER) | US FDA
CDR Brandon C. Heitmeier, MPH, CPH, CPGP
Consumer Safety Officer
Division of Compounding I
OCQC | OC | CDER | FDA