Preparing for an FDA Inspection

This program will focus on preparing your company for a successful FDA inspection. The course will focus on key GMP and Data Integrity guidelines and can be customized to address on-going data integrity or GMP issues at your facility. 

Our dynamic instructors will help your team understand why procedures are in place and what the ramifications to the company can be if Quality procedures are not followed. 

This training can be customized to meet your company’s specific needs and would be appropriate for sponsor organizations including pharmaceutical, biotech, and medical device organizations, CMOs, packaging/labeling contractors, analytical laboratories, and warehouse and distribution center personnel. 

You can select from our listed topics or we can incorporate other relevant topics that you request. 

Examples of 483s, Warning Letters or other official action will be included, as appropriate.

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Suggested Topics

  • FDA systems-based and risk-based inspectional philosophy 
  • Developing an inspection checklist
  • Conducting mock inspections
  • Reviewing the guidance documents that FDA provides to its inspectors
  • Critical review of recent Warning Letters and Consent Decrees
  • What to expect when FDA comes
  • How European inspections differ from US Inspections, and how to prepare for the QP inspection
  • Critical SOPs of interest to FDA

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