CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Understanding the GMP requirements of each component is critical to product and compliance success.
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Drop the checkbox mentality and embrace accountability and understanding.
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.
The agency has issued its list of the most common inspectional observations for FY 2017.
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.