FDA's Quality Metrics - Latest Advances

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Category Quality Managers, Quality Engineers, Small Business Owners, Quality Metrics

Deadline: March 13, 2019 | Date: March 14, 2019

Venue/Country: Online, U.S.A

Updated: 2019-01-31 18:21:50 (GMT+9)

Call For Papers - CFP

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Draft Guidance for Industry: Request for Quality Metrics

Background

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?

References

Who Will Benefit

Quality Managers

Quality Engineers

Small Business Owners

GxP

Consultants

Quality VPs

IT 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.