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    Category: Cleaning and Disinfection

    FDA 483 #10 – Non-Viable Particle Counting

    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…

    Seth DePasquale, R.Ph., BCSCP November 6, 2020
    0 Comments

    483 Friday #7 – Viable Air Sampling

    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…

    Seth DePasquale, R.Ph., BCSCP October 2, 2020
    0 Comments

    483 #6 – Cross-Contamination

    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…

    Seth DePasquale, R.Ph., BCSCP September 25, 2020
    0 Comments

    WARNING: Hazardous Drug Spill; HOW TO CLEAN UP

    Hazardous Cleanup I’ve had a few people contact me about the process for cleaning up a hazardous drug per <800>. It’s slightly different than what…

    Seth DePasquale, R.Ph., BCSCP September 25, 2020
    0 Comments

    Cleaning up Confusion; correctly cleaning your room

    Before we get started… I actually have an entire video series on cleaning and disinfection in the Sterile Compounding Course. I go over a number…

    Seth DePasquale, R.Ph., BCSCP September 22, 2020
    2 Comments

    FDA to USP: Sterility is top concern with extended BUDs

    Tomorrow, September 15, 2020, the USP will be having a call for comments regarding the appeals related to extending Beyond Use Dates in USP Chapter…

    Seth DePasquale, R.Ph., BCSCP September 14, 2020
    0 Comments

    Getting an FDA “Close Out Letter”

    An FDA Inspection So you’ve been visited by the FDA and whether you’re a seasoned QA manager at a major pharmaceutical manufacturer or the pharmacist…

    Seth DePasquale, R.Ph., BCSCP August 27, 2020
    0 Comments

    483 #2 – Facilities & Equipment

    Learning Objectives Explain the conditions USP Chapter <797> states for surfaces in classified areas Discuss what USP Chapter <797> says about gaps in ceiling tiles…

    Seth DePasquale, R.Ph., BCSCP August 21, 2020
    0 Comments

    Pharmacy Inspection Podcast Episode 31 – Melissa Stefko

    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…

    Seth DePasquale, R.Ph., BCSCP October 12, 2018
    0 Comments

    Pharmacy Inspection Podcast Episode 27 – RECORDED – USP 797 Proposed Revision with Jon Pritchett

    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…

    Seth DePasquale, R.Ph., BCSCP July 31, 2018
    0 Comments
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    Recent Posts

    • FDA 483 #10 – Non-Viable Particle Counting
    • FDA 483 #9 – Bacterial Endotoxin Testing
    • Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?
    • Can we share Stability Studies?
    • FDA 483 #8 – Using ungraded ingredients

    Recent Comments

    • Bret Snow on You received a 483? Don’t Panic…
    • Rick Meyer on Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
    • Seth DePasquale, R.Ph., BCSCP on Cleaning up Confusion; correctly cleaning your room
    • Rick Meyer on Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust
    • Seth on 483 #3 – Smoke Studies and Media Fills
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    Pharmacy Inspection Podcast Episode 27 - RECORDED - USP 797 Proposed Revision with Jon Pritchett

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