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Pharmacy Inspection Podcast

  • Greg Stanley - IV Workflow

    15 APR 2022 · 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 and USP .  His oversight includes sterile compounding, hazardous compounding, and robotic/automated technologies. 
    Ascoltato 32 min. 56 sec.
  • Pharmacy Inspection Podcast - Cleanrooms!

    18 GEN 2022 · 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).
    Ascoltato 31 min. 25 sec.
  • Pharmacy Inspection Podcast - Building a Compliance Team

    21 DIC 2021 · 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.
    Ascoltato 22 min. 53 sec.
  • USP 797 Revision

    26 NOV 2021 · In this episode of the pharmacy inspection podcast I go over some of the changes to USP in the latest revision to the chapter.
    Ascoltato 28 min. 59 sec.
  • USP 795 Revisions

    8 OTT 2021 · In this episode we go over some of the major changes in the revision to USP Chapter and what you need to potentially know if it becomes finalized.
    Ascoltato 18 min. 11 sec.
  • FDA 483 #10 – Non-Viable Particle Counting

    6 NOV 2020 · In todays 483 we're going to be looking at non-viable particle counts otherwise and more accurately known as total particle counts and why they're so important. So let's take a look at the 483 observation first then we'll dive into it a little deeper.
    Ascoltato 11 min. 44 sec.
  • FDA 483 #9 – Bacterial Endotoxin Testing

    16 OTT 2020 · In this weeks' 483 we're going to be talking about Bacterial Endotoxins and the testing related to endotoxins. Let's first take a look at the observation then we'll discuss what endotoxins are and why it's important to keep them out of your preparations.
    Ascoltato 10 min. 5 sec.
  • Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?

    13 OTT 2020 · I am going to be talking today about something that is maybe a little bit controversial, but has been brought up at the last public forum that USP had in regards to the appeals to  797,  795. And that’s talking about shared stability studies Or a shared database of stability studies that multiple pharmacies could share amongst themselves. 
    Ascoltato 8 min. 37 sec.
  • FDA 483 #8 - Using ungraded ingredients

    9 OTT 2020 · In this weeks 483 Friday we're going to be talking about the use of ungraded ingredients in pharmaceutical preparations. First, I'd like to show you a 483 where this was done, then we'll look at a case where non-USP ingredients led to real issues in patients where the drug product contained non-USP graded ingredients.
    Ascoltato 12 min. 17 sec.
  • Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust

    6 OTT 2020 · This week Bryan discusses the use of a HEPA filter prior to exhausting out of a building with a non-sterile USP compliant room - Is it necessary?
    Ascoltato 9 min. 57 sec.
The Pharmacy Inspection podcast is a show dedicated to discussing issues and topics related to sterile and non-sterile pharmacy compounding and compliance with industry standards.
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