Conducting Effective Quality Audits: Beyond Audit Checklists 2015

Topics

• Purpose of Quality Audits in pharmaceutical or medical device companies
• Overview of Regulatory Requirements for Quality Audits
• Conducting the Audit
• Audit Preparation/Audit Plan
• Area Tours
• Introductory Meeting/Orientation
• Interviews
• Document Review
• What is/is not an Audit Finding?
• Time Management
• Audit Wrap-Up Meeting
• Classifying Audit Findings
• Key Elements of the Audit Report

Who should Attend

• Audit Managers
• Quality Managers
• Quality Auditors
• Lead Quality Auditors
• Reviewers and approvers of Quality Audit Reports
• Regulatory Affairs Managers
• Quality Assurance Management responsible for Quality Audit Systems