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…
Month: August 2020
You received a 483? Don’t Panic…
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…
483 #1 – Aseptic Technique 101
Learning Objectives: Discuss proper ways to compound inside the primary engineering control and potential risks of having exposed skin while compounding Explain what must be…
LyceumCE is all about Quality Improvement
Hi, my name is Seth DePasquale. I’m a Board Certified in Sterile Compounding Pharmacist. I’ll give you a little bit of background on myself, but…