What to expect during an FDA Inspection:
Preparing for an FDA Inspection requires the knowledge of
what to expect during an actual inspection. This training
session will cover what should be expected during an FDA Inspection.
It is a great first step in preparing for the FDA and is best
taken in conjunction with the "How To Manage an FDA Inspection" session.
How to Manage an FDA Inspection:
Your company must have procedures in place that detail what
happens, who does what, who the key people are that will take part in
the inspection, back-up personnel, designated areas, and other details
pertinent to the inspection. From the moment the FDA walks in
your door, the processes you have in place to manage the inspection
should kick in and work like a well oiled machine. If you don't
have these policies or the people in place to execute them, this
session is for you. The session is great as a stand alone
session, but is best combined with the "What to Expect During and FDA
Inspection" session.
Mock FDA Inspections:
The best way to know how prepared you are for an FDA Inspection
is to practice. We offer mock inspections that will simulate the
real thing so that you can try out your inspection procedures in a safe
environment. This is the best way to be truly prepared for the
FDA! |
Internal Quality Audits:
Our ASQ Certified Quality Auditors come to your company to
help you create your own internal auditing program, or will manage your
program for you on a contract basist.
Supplier Audits:
Our audit team can conduct supplier quality audits at your
suppliers, on your company's behalf. We do the work so you don't
have to.
GMP Compliance Audits:
OUr audit team will conduct a GMP compliance audit to see where
your organization stands in comparison to current GMP regulations, and
porvide you with a comprehensive gap analysis report. This report
will identify the areas you are in compliance, where you are not, and
make recommendations to bring you into compliance.
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Our team will help you creat the needed and required documents:
- SOP Creation (Standard Operating Procedures
- Quality System Review & Creation
- Material, Component, and Product Specifications
- Master Records
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