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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 Science…
 
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).…
 
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 standardizatio…
 
Learning Objectives Discuss the importance of particulate in relation to microorganisms Explain why 0.5 micron and larger sized particles are of great importance Discuss 3 ways that we can minimize the number of particles in our cleanroom In todays 483 we're going to be looking at non-viable particle counts otherwise and more accurately known as to…
 
Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various routes of administration Discuss ways to control the levels of endotoxins in final preparations In this weeks' 483 we're going to be talking about Bacterial Endotoxins and the testing related to endotoxins.…
 
Learning Objectives Discuss the use of USP graded ingredients in pharmaceutical preparations and the importance Explain what prompted the FD&C act of 1938 to be enacted 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 …
 
Learning Objectives Explain the purpose of viable air sampling Discuss how conclusions can be made from the results of viable air sampling Happy Friday! 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 cleanline…
 
The learning objectives for this week’s 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be used to deactivate hazardous drugs Discuss the 4 steps required to properly remove hazardous drugs from surfaces and equipment In this week's 483 we're going to look at the importanc…
 
The learning objectives for this week's 483: Explain the typical out of specification range of potency for many compounded formulations Discuss a type of testing that is both economical and scientifically sound Discuss the 5 elements of an SOP on potency testing should include This week we'll be looking at one observation the FDA made at a facility…
 
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.By Seth DePasquale
 
Having issues controlling temperature in your cleanroom? Here's what NOT to do and what you should do... Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM iHeart Spotify Radio Public Pocket Casts over cast Cast box Podcast App Breaker Google Podcasts iTunes Podbean…
 
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 compliance for seeking accreditation. We'll be having a discussion on compliance with USP , specifically about…
 
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-compounders-guide-to-hazardous-drug-compounding-workflow/ Join us for the USP Hazardous Drug Workflow & Containment …
 
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 Academy Manager at Fagron educating pharmacists and technicians. She has a wealth of knowledge when it comes t…
 
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. Ms Stefko is an experienced Pharmaceutical and Biotechnology professional with a background in Quality Assu…
 
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. Found out more about the ACHC Designated Person Course HERE! (https://accreditationuniversity.com/hdhdp) Watch the Lean 6 Sigma Process impro…
 
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 a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: [caption id="attachment_16757" alig…
 
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 extremely helpful from the the perspective of the PIC; who at any moment could be doing any number of thin…
 
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 the proposed revisions of 797. Join Jon Pritchett, Bryan Prince and I for a SPECIAL EDITION of the Pharmac…
 
This week we broadcast our interview that we recorded at CCH in June. Bryan was able to sit down with Jeanine Sinanan-Sing, co-founder and CEO of Vitae Industries, maker of the AutoCompounder 3D printer . They talk about their platform and the exciting possibilities available with its use. Thanks again to our sponsor for CCH: Encore Scientific. If …
 
This week we welcome Kim Kieffer! 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 Academy Manager at Fagron educating pharmacists and technicians. She has a wealth of knowledge when it comes to formulations …
 
This week we welcome Christine Roussel, assistant Director of Pharmacy at Doylestown Hospital in Pennsylvania and Program Facilitator for Medisca's LP3 Network. This was a great conversation about containment practices and we really hope to have her on again sometime soon! WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from Ph…
 
This week we welcome Greg Stowell, Education and Consulting Manager for Accreditation University. We discuss how ACHC is helping to bring continuous quality education to compounders. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id="14886"] If you like the podcast follow us on twitter …
 
On April 20th the USP had an online open forum where they discussed the proposed revision of 795. Today on the show Bryan and Seth discuss some of the proposed changes to 795. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @Pharma…
 
This week we welcome Lauren Bernick, Director of Advertising for the International Journal of Pharmaceutical Compounding. Lauren also runs a website called wellelephant.com, where she consults on nutrition using a whole foods, plant based diet. This week we talk about how compounders could expand their business and brand using nutrition/wellness an…
 
This week Bryan and I discuss the differences between endotoxin and endospores; diving a little deeper into the post from last week. We talk about the basics of these two, why they're important and how to kill or deactivate them. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id="14886"…
 
This week we welcome Donnie Calhoun, Pharmacist, Pharmacy owner and CEO & Executive Director for the American College of Apothecaries (ACA). Donnie brings a lot of experience and knowledge to the podcast this week as we discuss the topic of education within compounding including the future of pharmacy and the ACA's role in providing pharmacists wit…
 
This week we welcome Denise Frank, Pharmacist, Consultant, Educator...within compounding Denise has done a LOT! We met Denise at the ACA meeting in Florida and had to have her on the podcast. Denise has also worked for the National Associations of Boards of Pharmacy and helped developed the program for how they inspect compounding pharmacies. Denis…
 
This week we welcome Erika Fallon, Supervising Pharmacist at Fallon Wellness Pharmacy to the podcast. Erika is heavily involved in the International Academy of Compounding Pharmacists as she is on their Board of Directors and also sits on the legislative committee as well. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from Ph…
 
This week Bryan and I discuss proper donning and doffing of Personal Protective Equipment (PPE) - there seems to be much discussion this topic and how to perform properly when it comes to hazardous drug handling. Honestly, I think this is still open for debate on how to do correctly and maybe there's more than 1 way to get it done. Let's discuss! W…
 
In our 15th episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transiti…
 
This week we welcome Herschell Hitchcock, President of EOC1 to the podcast. Herschell is an industrial hygienist by training and has a ton of experience in how exactly cleanrooms work and how to troubleshoot problems when something goes wrong. His company EOC1 also certifies and maintains cleanrooms for a number of clients all over the United State…
 
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 compliance for seeking accreditation. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates fro…
 
This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of Pharmaceutical Compounding (click here) and has been an outspoken advocate for improving quality in compounding as well as advising on multiple committees for the United States Pharmacopeia and the FDA. WE'RE NOW ON iHEART RADIO PODCAST…
 
Java Coleman joins us this week. He is a consultant for the pharmaceutical industry through XLN Collaborative Consulting. Java has been working for many year now in the area of process improvement. He's also worked at large organizations like Fagron, Apex and Nestle in their operations and improvement divisions. Feel free to reach out to Java: jcol…
 
This week we talk with Rad Dillon. He is a pharmacist and certified surveyor and consultant for the Accreditation Commission for Health Care with a lot of experience performing PCAB accreditation audits. Rad also has experience in writing Standard Operating Procedures and pharmacy management. He's also attained the American Society for Quality's Qu…
 
In our 9th episode we speak with Joe Cabaliero and Bill Mixon. Both of these gentlemen have a history in compounding pharmacy that is interesting and impressive. Recently, they have submitted a proposal to include sterile compounding as one of the Board of Pharmacy Specialties (BPS). In this episode we discuss how the idea came about and some of th…
 
HAPPY NEW YEAR! Welcome to 2018. In our 8th episode we speak with James Brown and Dr. Wayne Dehaven of Pharmetric Laboratory. We'll be talking about the importance of method suitability, why it's necessary and what Pharmetric specializes in: Rapid Microbiological Sterility Testing. Their method allows pharmacies to get sterility results within 5 da…
 
In our 7th episode we speak with Jon Pritchett, Associate Director of Pharmacy for Accreditation Commission for Health Care. Jon has not only worked in compounding pharmacy for many years but is now director of pharmacy of the accrediting body that audits many compounding pharmacies throughout the country. This is a great discussion about USP 800, …
 
In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transit…
 
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