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’.
• 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
• 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