FDA's Quality Metrics - Latest Advances

Added 2 months ago by Joseph Wilcox on Health and Medicine
This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

Why should you Attend
This is a very important initiative for the FDA who is planning to use the quality metrics as part of their risk based inspection process. Consequently, putting the quality metrics program in place may reduce the inspection frequency at your facility.
Areas Covered in the Session
FDA Centers involved in Quality Metrics
The Issue
Draft Guidance for Industry: Request for Quality Metrics
Covered Drugs and Establishments
Quality Metrics FDA intends to calculate
Optional Quality Metrics that may be submitted
How FDA intends to use quality metrics
Sections indicated for public comment
FDA public meeting
FDA Public Meeting results
What about CDRH?
Who Will Benefit
Quality Managers
Quality Engineers
Small Business Owners
Quality VPs
Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

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