Pre-Approval Inspections
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?
BioPharm & 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
FDA’s New Guidance for Medical Device Data System and Medical Image Storage
What's new for Medical Devices regulated by the U.S. FDA? Find out what you need to know regarding Medical Device Data Systems and Medical Image Storage.
End of Year Quality Cleanup
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.
5 Things to Budget for in the New Year – Quality Reminder
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!
Help My FDA Inspection is 48 Hours Away!
Last minute FDA preparations. Are you frantically trying to prepare for an FDA inspection or Quality Audit and have very little time? Here is a listing of items you should prepare and review. If you still need a little help - Give us a call.
Getting Ready for a Quality Audit or FDA Inspection
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.
Mistakes to Avoid When Hiring a Quality Consultant
We understand that finding the right consultant for your project can be difficult, so here are a few things to keep in mind!