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…
Category: Cleaning and Disinfection
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…
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…
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…
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…
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…
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…
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…
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…
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…