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U.S. FDA Pre-Approval Inspections (PAI)

If you have worked in this industry for at least a few years you have probably heard the phrase “PAI” thrown about.  What is a PAI? Why is it important? And how can I best position my company and our product?

BioPharma & Medical Device Manufacturers Annual Checklist

Quality checklists are a great way to make sure you don’t forget the important things that keep your process and products in compliance. Here is a list of helpful items for Biopharm and Medical Device companies to consider annually. #QualityMatters

By |2021-10-20T03:16:51+00:00January 13th, 2020|Quality Checklist|0 Comments

Quality Checklist: Keep Your Quality System On Track With These Simple Reminders

Keep your Quality System on track with these simple reminders. This fun end-of-year quality checklist can be done any time of the year.

By |2022-02-08T02:06:00+00:00May 12th, 2019|Quality Checklist, Technical Article|0 Comments

5 Tips To Improve Your Quality Budget

5 things that many companies forget to budget for when making their annual quality budget. Take a look at these items to make sure you have budgeted enough dollars to make sense!

Getting Ready For Quality Audits And FDA Inspections

What can I do to get ready for a quality audit or inspection by the U.S. FDA? Who do I need to prepare on my site? What do I do about known gaps in our systems? Read this article to learn more.

By |2022-03-07T16:50:33+00:00August 1st, 2017|Quality Checklist, Technical Article|0 Comments
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