Inspection – Features

The Ultimate Guide to Researching Your FDA Inspector

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list.  And while you know you should set up a complete FDA inspection preparedness program, you just [...]

New FDA GMP Inspection Model

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted.  The FDA recently made available a description of their new operating model that will ensure integration of review and inspection [...]

10 Ways to Prepare for a GMP Inspection

How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities. This becomes especially complex for start-up companies that are virtual, or essentially [...]

By | 2018-02-14T11:54:54+00:00 January 26th, 2017|CGMP, FDA Inspections, FDAzilla, Inspection - Features|