The Center for Professional Advancement, New Brunswick, NJ
August 13-14, 2007
This overview course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:Regulatory Affairs
Quality Assurance
Auditing
Quality Control
Documentation Management
Research and Development
Plant Management
Executive Management
Engineering
Description:
This course provides a background and understanding of the role played by the Agency, it’s administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections, i.e. pre-approval inspections (PAI), routine GMP inspections, bioresearch monitoring inspections, quality systems inspections techniques (QSIT) applied to device companies and system-based inspections program applied to drug companies. A detailed description of the six systems will be provided. The course offers methodologies and techniques on: How a firm should prepare for an FDA inspection
Ways to train employees in view of the inspection
How to ensure that required documentation is in place
How to interact with the investigator—DO’s and DON’T’s
What companies should do when the inspection ends
How to reply to 483’s and warning letters
Legal implications of non-compliance
Post inspection actions The course consists of lectures, discussions, and a practical workshop which will enable participants to work in small groups and design a company policy/procedure for handling FDA inspections.
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