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.
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
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.
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.
