FDA Audit Preparation

• 21 CFR Part 820 - implementing all of the requirements into your system
• Key issues everyone in the organisation should know
• A system V's records focused inspection
• The Quality System Inspection Technique - QSIT
• How to evaluate your overall state of compliance
• Closing the gaps
• The Team factor
• Project Management of preparations
• Consequences of a poor inspection result
• Identifying appropriate Front-Line personnel for the inspection
• During the audit - key watchouts
• The format of the 483 observation
• The FDA Warning Letter
• Responding to Observations

Programme overview

This FDA audit preparation training course is a designed to introduce the trainee to the FDA audit auditing process  & tools required to effectively manage  the audit .

Who is the course for

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on getting ready for an FDA audit.

Learning outcomes

Learners will have a complete understanding of:

The FDA audit approach to the audit

How to evaluate your overall state of compliance

Become aware of the Key watch outs