CAPA is the foundation of an effective Quality Management System.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.
A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed.
Validation is an important element of the Quality System Regulations and ISO13485.