Description:
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.
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.
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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
Speaker: Andrew Campbell,
Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management.Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.
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To register/enquire, please contact:
www.compliance.world
Call us at this Toll Free number: +1-866-978-0800
