You can’t just validate processes—you have to monitor them, too.
Trust, but verify, your suppliers.
In just about any industry, this is a basic part of a quality system.
Prior to design verification of packaged products, consider the following process-related elements.
If you climb into FDA’s sandbox, be prepared to play by the rules.
Regardless, let’s look at stupidity in its highest form.
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
Comply all the time, not just when FDA announces an inspection.
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.