ResearchBib Share Your Research, Maximize Your Social Impacts
Sign for Notice Everyday Sign up >> Login

FDA inspection 2020 - Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?



VenueHollywood, Online Online



Topics/Call fo Papers

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
SME (Subject Matter Expert) training
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.

Last modified: 2020-10-14 18:37:53