This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
This webinar will help attendees understand the fundamental audit steps and how to perform them properly. It will focus on audit planning, audit conduct, audit findings, and the audit report. The importance of interview techniques, critical evaluation skills and avoidance of audit bias will also be discussed.
Why Should You Attend:
Auditing is a critical function within a pharmaceutical or medical device company. Properly performed audits help to ensure that audited parties are operating in accordance with regulatory requirements, procedures, supply/quality agreements, etc. Ultimately audits are a key contributor in ensuring product quality and regulatory compliance.This webinar will help attendees understand the fundamental audit steps and how to perform them properly. It will focus on audit planning, audit conduct, audit findings, and the audit report. The importance of interview techniques, critical evaluation skills and avoidance of audit bias will also be discussed.
Areas Covered in the Webinar:
- Overview of Regulatory Requirements for Quality Audits
- Purpose of Quality Audits
- Audit Preparation/Audit Plan
- Conducting the Audit
- Introductory Meeting/Orientation
- Area Tours
- Document Review
- Interviews
- Time Management
- What is/is not an Audit Finding?
- Classifying Audit Findings
- Audit Wrap-Up Meeting
- Key Elements of the Audit Report
Who Will Benefit:
- Quality Managers
- Audit Managers
- Lead Quality Auditors
- Quality Auditors
- Regulatory Affairs Managers
- Reviewers and approvers of Quality Audit Reports
- Quality Assurance Management responsible for Quality Audit Systems
Course Provider
Andrew Campbell,
