Quality Considerations for Drug-Device Combination Products
Understanding the GMP requirements of each component is critical to product and compliance success.
Tag Archives: Quality System Regulation
What, No Installation Records?
FDA expects all installation activities to be documented.
3-D Printing: Forgotten by the New EU Medical Device Regulation?
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
Statistical Techniques: Zero for 11
Every company should understand the value of employing statistics to assist in running a business.
FDA a Pain in the Butt for Hemorrhoid Management System Establishment
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
Gasoline in the Stockroom, Burning Down the House!
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
If It Walks Like a Duck and Quacks Like a Duck It’s Probably a Duck
Device establishments should be able to read and comprehend 21 CFR Part 807.
FDA Cites Failure to Assess Product Risk in Warning Letter
Comply all the time, not just when FDA announces an inspection.
Only Two Form 483 Observations Can Equate to a Warning Letter
You must have established procedures for complaint management and MDRs.
Establishments Must Calibrate and Maintain their Equipment, Who Knew?
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
