Preparing for and Surviving an FDA Inspection
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
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 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.
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 procedure for handling FDA inspections.
Attend this course and its companion course
Save $400 off combined regular tuition!
Documentation Management and
Control
October 1–2, 2012 • New Brunswick, NJ
Course ID #1866