Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
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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/Control
• Management
• Auditing
• Engineering
• Research & Development
• Quality Systems Management
• Documentation Management
The course will focus on various types of inspections in the
pharmaceutical and related industries and will look at policies,
procedures and experiences relevant to those inspections.
Description
This course provides an overview of the FDA inspection
process in general and of particulars applicable to “foreign
inspections”. It provides a background and understanding of
the role played by the Agency, its administrative and
enforcement powers. The course provides a step by step
description of the inspectional process with specific examples
regarding cGMP compliance inspections and pre-approval
inspections.
The latest FDA initiatives regarding inspections, like risk based
approach and system based approach, will be discussed in
detail. This will enable participants to better understand how to
prepare their companies for FDA inspections.
The course consists of lectures, discussions, case studies
analysis, and a hands-on workshop in setting up a company
policy/procedure for handling inspections.
Attend this course and its companion course, Auditing for cGMP Compliance, ID#1881 (Offering# 1006-303) and save $400 off the combined regular tuition. (Note: Only one discount applies)