• Defining audits
  • Audit types and classification
  • Why audits are conducted
  • The auditing process
  • Responding to the audit report
  • US FDA 6 system inspection model
  • Form 482,483, 484 and warning letters
  • Interacting with auditors
  • Self inspection
  • Self inspection report and CAPA

Understanding the "Why" and "How" of GMP Audits

This GMP course is specifically designed to explain the fundamental concepts of GMP auditing for the pharmaceutical industry, including regulatory audits and self inspections.

What's inside

  • Defining audits
  • Audit types and classification
  • Why audits are conducted
  • The auditing process
  • Responding to the audit report
  • US FDA 6 system inspection model
  • Form 482,483, 484 and warning letters
  • Interacting with auditors
  • Self inspection
  • Self inspection report and CAPA

Additional information

Who is it for

This course is designed as basic training for all personnel involved in GMP operations. It is also valuable for management personnel at pharmaceutical and medical devices companies in order to get an overview of the auditing process.

Why it matters

Auditing is a critical function within a pharmaceutical company. While audits are frequent, most employees are not aware of the process of regulatory audits, US FDA’s approach to audits, importance of self inspections and their specific roles during an audit. Understanding these fundamentals can lead to more coordinated, predictable, and successful audits.