  In this week's 483 we're going to talk about investigating microbial contaminations inside the cleanroom to find out possible sources and remediate the issue. We're also going to talk about writing up that investigation and the resulting corrective action/preventive action or CAPA as a result.    

Pharmacy Inspection Podcast - Episode 41 - 483 #4 - Investigations & CAPAs

The SterileAF Podcast is a show dedicated to discussing issues and topics related to sterile and non-sterile pharmacy compounding and compliance with industry standards.

Medicine

Science & Medicine

Health & Fitness

Thanks for tuning in to the Pharmacy Inspection Podcast! Today we have Pharmacist Greg Stanley on the show and we're going to be talking about implementation of an IV workflow system! Greg Stanley received his Bachelor of Science in Pharmacy degree in 1998, having also completed undergraduate research fellowships in Biological/Environmental Sciences and Polymer Sciences.  He has over twenty-five years of experience with compounded sterile products; both in hospital and home infusion settings.  Greg has extensive experience with policy development, staff training, pharmacy management and regulatory compliance.  Currently, Greg is an Associate Director at SUNY Upstate Medical University.  He is involved with several projects related to USP <797> and USP <800>.  His oversight includes sterile compounding, hazardous compounding, and robotic/automated technologies. 

Greg Stanley - IV Workflow

In this weeks episode we welcome Bryan Prince back to the show to talk about cleanrooms. We discuss common issues that we see with cleanrooms, talk about particle counts and certification reports as well as some cool technology being used to simulate a cleanroom before it's even built (computational fluid dynamics - CFD).

Pharmacy Inspection Podcast - Cleanrooms!

Today on the podcast we welcome Lilit Smith. Lilit is a board certified sterile compounding pharmacist and is currently the Manager of Compounding and Compliance at Baptist Health South Florida. In her role she supports across the pharmacy enterprise with cleanroom design and construction, regulatory compliance and process and policy standardization. We're going to be talking about her experience with building a compliance team to oversee compounding operations at a large health system.

Pharmacy Inspection Podcast - Building a Compliance Team

In this episode of the pharmacy inspection podcast I go over some of the changes to USP <797> in the latest revision to the chapter.

USP 797 Revision

In this episode we go over some of the major changes in the revision to USP Chapter <795> and what you need to potentially know if it becomes finalized.

Pharmacy Inspection Podcast - Episode 41 - 483 #4 - Investigations & CAPAs

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