FDA inspection 2021 - Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?

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.
An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stress and lead to much more favourable results.
FDA Inspection approach
Inspection preparedness strategy and planning
Key roles during an inspection
Speaker:
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.