J27 Inspection Readiness

The Course

This course enables delegates to develop an effective strategy to plan and prepare efficiently for an audit/inspection through understanding the process and procedures.  Delegates will learn to recognise and prioritise methodologies to enable them to prepare for a successful audit/inspection and identify key stakeholders in the process. The course will explore how to reduce the anxiety of audits/inspections by having an effective strategy to be ‘audit ready’.

 

Learning Objectives

• Outline the process and procedures of an audit/inspection • Appreciate the process from the auditors perspective • Recognize and prioritize methodologies to prepare for an audit/inspection • Identify key stakeholders in the audit/inspection process • Plan and prepare efficiently for an audit/inspection  • Be able to respond to audit/inspection findings

Course Outline

• What constitutes an audit /Inspection • What will be audited /Inspected  • QA, checking , QC and monitoring  • Preparation and organisation for an Audit • Be a company that is Audit ready • The Trial Master File • Audit Trails & file notes • What will happen on the day? • Introductory meeting • Interviews & Questions • The exit meeting  • Responding to audit /inspection findings • What can go wrong and what will go well • Lessons learned