Seth DePasquale
Pharmacy Inspection PodcastEpisodes
Episodes of Pharmacy Inspection Podcast
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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
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 pre
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
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 issu
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?
This weeks 483 we're going to focus on viable air sampling, which is one part of an environmental sampling plan. The information gained from viable air sampling can be very telling of the cleanliness and control you have over your cleanroom.
Bryan will be talking about some of the unintended consequences of implementing USP 800 and this particular story he is going to tell you was incredibly expensive...
In this week's 483 we're going to look at the importance of cleaning work and non-work surfaces to prevent cross-contamination. What's interesting about this particular 483 is that the FDA doesn't note this on sterile products, but an operation
This week we'll be looking at one observation the FDA made at a facility concerning the potency testing of their drug products. While there's not much direction given to pharmacies through USP Chapter , there's still a need for testing this cri
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 correc
Learning Objectives Explain how action levels are used to maintain a controlled environment Define the 5 steps to DMAIC Explain the 5 why's technique for finding a root cause Discuss the proper documentation for documenting a deviation In
Bryan lays out two mistakes that he recently came across in a very well designed 3D model of a cleanroom...the only problem, there were two fairly critical mistakes. Don't make these mistakes...
Are you paying too much for viable sampling when you certify your cleanroom? This week we discuss how the lack of guidance for viable sampling is potentially costing you!
This week we discuss Environmental Sampling Plans…who should be deciding where and how to sample at your facility?
Bryan discusses the proper materials of construction for a USP compliant cleanroom
Pharmacy Inspection Podcast - Episode 36 - Controlling Temperature by putting holes in my cleanroom?
Bryan discusses a question he received about controlling heat in a negative pressure cleanroom
This week Bryan recounts a project he came in halfway finished (or so they thought) to find the selection of the HVAC equipment was NOT compliant with USP !
This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their pharmacy careers as technicians over 30 years at an Air Force Base and now consult pharmacies, large and small, in compounding comp
This week we welcome Tom Kupiec to the podcast. Tom is the owner of ARL (Analytical Research Laboratories) Oklahoma City, Oklahoma. To learn more about the contamination control webinar go to: https://pharmacyinspection.com/product/a-co
This week we welcome Kim Kieffer to the podcast. Kim is the Director of Corporate Relations at Empower Pharmacy in Houston Texas. She’s been a compounding consultant at Spectrum, Letco and Freedom Pharmaceuticals. Most recently she was the Acad
This week we welcome Melissa Stefko, from Wells Pharmacy Network to the podcast. Melissa Stefko, Senior Director of Quality for 503B Wells Pharmacy Network, will be discussing contamination control as it relates to pharmaceutical compounding. M
This week Greg Stowell and Jon Pritchett from PCAB (ACHC) speak with us about a new course they've released that teaches you all about becoming compliant with the Designated Person requirement within USP 800. Watch the Lean 6 Sigma Process impr
This week Bryan and I talk about Process Improvement! We give specific examples of how to start out improving a few processes within your own pharmacy. Announcement: Upcoming FREE Webinar! SIGN UP HERE (CLICK HERE) Do you have
This week Bryan and I talk about Compounding Design Theory! This podcast stemmed from a conversation Bryan and I had about a hood that he helped design for Encore Scientific (pictured on left); a hood with a clear view from any angle. Which is
Thanks SO so much for everyone that did tune in; I promise next live event I will DEFINITELY RAISE THE BAR!!! I've fixed most of the audio issues and I believe we'll revisit this conversation again the very near future! LAST WEEK USP announced
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