FDA Mock Audits (QSIT Audit) Workshop

Course Description
Inspections by the FDA can be challenging and there are consequences if you do not meet the requirements. This course is designed to provide pharmaceutical professionals with the information required to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI). For the latter, it details what the FDA looks for, among other related, in-depth topics. Mock audits are useful tools that help identify non-compliance and gaps beforehand. Furthermore, they provide an understanding of where issues lie, in order to address them proactively and effectively, before an actual inspection occurs by the FDA.

Who Should Attend
This course is designed for pharmaceutical professionals.

Learning Objectives
Through training, participants will learn:

  • The purposes of FDA’s Pre-Approval Inspections (PAIs), mock audits, and strategy used for the latter
  • DOs and DON’Ts to prepare for the referred inspections and audits
  • Details of each PAI objective, so they are prepared for this type of inspection during pre and post submission stages of a drug product and are able to meet related project completion and approval timeframes to market a product commercially

Course Outline

  • Purpose of Inspections and a Mock Audit
  • Strategy for Mock Audits
  • Findings and Deficiencies to Withhold Approval of an Application
  • Domestic/International PAIs and Types of PAIs
  • Priority Pre-Approval Inspections
  • Overall Overview of the Three Primary Inspectional Objectives Regarding the PAI Program
  • Priority Pre-Approval Inspection- FDA Recommendations and Reasons for Not Conducting this type of PAI
  • Reasons for Conducting a Discretionary Pre-Approval Inspection and Investigator Preparation before a PAI
  • PAI-Type and Depth of Inspection/Audit Coverage, Objectives, and Techniques
  • PAI Inspection Reporting
  • PAI Inspection Reporting and Sample Collection or Sample Submission Requests
  • FDA Laboratory Analysis of Samples
  • Findings That May Result in an FDA-483
  • Impact of a Negative PAI Report


Course Format
16 hours
Combination lecture and classroom exercises
Available on-site at your organization, at QSG’s facilities, and virtually

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