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University of California San Diego
Distance: 1.9 Mi300 Lakeside Dr
94666-0001 Oakland -
NovaBay Pharmaceuticals
Distance: 4.2 Mi5980 Horton St Ste 550
94608-2045 Emeryville -
RelayHealth Corporation
Distance: 4.2 Mi1900 Powell St Ste 600
94608 Emeryville -
Adamas Pharmaceuticals, Inc.
Distance: 4.2 Mi1900 Powell St Ste 1050
94608-2437 Emeryville -
OnPoint Analytics, Inc
Distance: 4.2 Mi1900 Powell St Ste 150
94608-1837 Emeryville
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Description
FDAReady has worked with clients to establish quality systems, inspection preparedness, and quality agreements for both sides.
A Gap Analysis is a cooperative audit designed to identify compliance problems, develop solutions, and prioritize the necessary actions. An FDAReady Gap Analysis combines the expertise of a company's staff with insightful audit techniques. Everyone is encouraged to openly discuss problems. Working as a team, we develop a reasonably comprehensive program for reaching substantial compliance.
In the restaurant of compliance, the Gap Analysis checks the food, and the mock inspection checks the service and decor. A mock inspection is a full dress rehearsal for an FDA inspection. Mock inspections are training in answering questions asked by a law enforcement agency. Are you answering their questions completely? Are you being accurate? Do you have the right people answering the right questions? Can you prepare the responses to hard questions? Compliance notwithstanding, do things look right? Unlike other consultants, FDAReady provides full dress rehearsals. There are no time-outs.