PTI - international

Agenda: Day One

I. Define the Essential Principles of Auditing

• Clarify roles and responsibilities of auditor and auditee
• Describe various types of audits
• Clarify the concepts behind compliance auditing
• Explain audit principles and objectives
• Identify key activities for a successful audit

Exercise: Review Participants' Backgrounds and Experiences with Auditing

II. Examine Regulatory Requirements to Ensure Compliance

• Identify the commonalities amongst the GxP requirements
• Analyze the specific requirements for GMPs, GLPs and GCPs
• Determine what documentation is required

Exercise: Create a Table Comparing the GxP Requirements

III. Risk-Management

• Determine what to look for and how to find it
• Apply a risk-based approach to your audit
• Evaluate benefits and drawbacks of checklists as an auditing tool
• Incorporate proven strategies into checklist development and audit planning
• Define critical competencies needed to be a conscientious auditor

Exercise: Apply a Risk-Based Approach to a Sample GCP and GLP Audit Reports 

IV. Ensure that Proper, Organized Documentation is in Place

• Describe key benefits of successful audits and the impact of good document control and training
• Prepare for a documentation audit
• Determine what to look for, how much to look for and how to review documentation
• Record and report objective facts
• Implement effective supplier evaluation practices
• Describe the benefit of self-assessment(s)
• Ensure responsibility and accountability within the audit framework

Exercise: Use Techniques Acquired in Class to Uncover Audit Findings