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Course ID:
1880

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Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites

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:

  • Top Management
  • Quality Assurance/Control
  • Regulatory Affairs
  • 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.

SAVE $400!
Take this course and its Companion Course:
Documentation Management and Control
7-8 June 2012, ID# 1866, Offering# 1206-203 and save $400 off the combined Regular Registration tuition.

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