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Inspection Preparation

/Inspection Preparation
Inspection Preparation 2018-02-14T11:42:35+00:00

  • The Ultimate Guide to Researching Your FDA Inspector

The Ultimate Guide to Researching Your FDA Inspector

February 9th, 2018|0 Comments

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 [...]

  • New FDA GMP Inspection Model

New FDA GMP Inspection Model

September 25th, 2017|1 Comment

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 [...]

  • 10 Ways to Prepare for a GMP Inspection

10 Ways to Prepare for a GMP Inspection

January 26th, 2017|0 Comments

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 [...]

1906, 2018

How to Do A Keyword Search in FDA Warning Letters

By | June 19th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDAzilla, Food, Form FDA 483, Medical Devices, Supplier Management|0 Comments

Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...

1605, 2018

Ready to Make Your Job a Whole Lot Easier?

By | May 16th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, FDA Warning Letters, FDAzilla, Food, Form FDA 483, Medical Devices|0 Comments

We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time.