FDA 483 #9 – Bacterial Endotoxin Testing
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…
Tag: 483
483 #4 – Investigations & CAPAs
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…
483 #3 – Smoke Studies and Media Fills
Learning Objectives Explain the purpose of smoke studies Define the two types of smoke studies that need to be performed Explain the two conditions under…
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…
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…