Preparing for and Surviving an FDA Inspection
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This course is available as a client site course. Please click here for more information.
Who Should Attend
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, its 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 medical
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.