Preparing Successfully for a US FDA Medical Device Inspection
It is more important than ever for medical device manufacturers to effectively prepare for US FDA medical device inspections.
For US companies, effective preparation can lead to shorter inspections with less disruption to company operations than occurs when inspections result in the identification of multiple quality system regulation (QSR) problems.
For non-US companies, effective preparation can lead to inspections with no or few nonconformities and can avoid the identification serious nonconformities that in the worst case could lead to an US FDA Warning Letter or even auto-detention - this means that the product is stopped at the US entry port and not allowed to be shipped to its destination.
In this course we will review what is important for successful QSR inspection preparation.
Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend the basic regulatory framework upon which inspections are based.
- Identify which US FDA regulations and requirements will be inspected, which are not limited to quality system regulations (QSR), but include other regulations as well.
- Conduct effective internal audits. This is the single most important activity for avoiding problems during US FDA inspections.
- Demonstrate the US FDA quality system inspection technique and
- Plan actions before, during and after the inspection.
- Quality Assurance personnel who need to ensure compliance with US quality system requirements
- Executive management who are the most senior officials notified by FDA of an inspection
- Department heads (warehouse, production, quality control, purchasing, others) who may need to respond to FDA questions during an FDA inspection
- Medical device personnel who may be observed carrying out their duties during an FDA inspection
- Human resources responsible for training and personnel qualification documentation
Overview of US FDA Quality System Regulation