Change is Here: Complying with the 2022 Version of USP General Chapter 797 - On Demand
Recorded On: 11/09/2022
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The wait is over! With the release of USP General Chapter <797> on November 1, 2022, sterile compounding organizations can finally move forward with implementing a higher standard of patient care. This webinar will highlight the major changes to USP General Chapter <797>, focusing on beyond-use dating, personnel training and competencies, viable sampling, and quality management. Nuance changes that significantly impact sterile compounding operations will also be discussed.
Learning Objectives:
- Identifying the major chapter changes between the 2008 and 2022 version of USP <797>.
- Differentiate between Category 1, 2, and 3 compounded sterile preparations (CSPs) and list the specific requirements for each.
- Explain the requirements of the chapter defined competencies.
- List the required frequencies for viable air and surface sampling, based on the Category of CSPs compounded.
- Describe the components of an effective sterile compounding quality management system.
Abby Roth, BS, CMQ/OE
Founder
Pure Microbiology
Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
No Disclosures to Report
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