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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

FDA RESOURCES

• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry | FDA
• Insanitary Conditions at Compounding Facilities | Guidance for Industry | FDA
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice | Guidance for Industry | FDA
• Microbiological Quality Considerations in Non-Sterile Drug Manufacturing | Draft Guidance for Industry | FDA
• Human Drug Compounding | FDA
• Compounding Quality Center of Excellence | FDA

CONTINUING EDUCATION (CE)

Registration and real-time attendance via available online rooms are required.

This course has been approved for 1.50 contact hours of continuing education for physicians, pharmacists, and nurses. For further details, see the detailed announcement.

Participants can also obtain a certificate of attendance, which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event.

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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