Conducting Effective Quality Audits: Beyond Audit Checklists

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

Andrew Campbell
Pharmaceutical Consultant, Quality & Compliance

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 & 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. Mr. Campbell 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 of written responses to inspectional observations.

Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as Director of Quality Systems.

Topic Background:

Your company has ultimate responsibility to ensure that all operations related to the manufacture, packaging, and testing of your products are conducted in compliance with applicable regulatory requirements. This includes in-house and outsourced operations. Furthermore, the FDA has recently placed increased focus on the need for companies to perform regular quality audits. Particular focus has been placed on the use of supplier audits to assure supply chain integrity. Therefore, conducting effective quality audits is essential to meeting regulatory requirements. Audits are also essential in identifying potential problem areas for improvement. Proactively identifying and making your own improvements is highly preferable to having a regulatory authority identify your problems for you.

Most companies have good audit procedures and trained auditors. However, effective quality audits require more than just determining IF a requirement is being met. It is equally as important to fully understand HOW the requirement is being met. As such, today’s audits must focus on objective evidence of WHAT is being done, and HOW it is being done. Audits must also be comprehensive, and focus on system-level issues. In order to meet these goals, auditors must have technical, process, and procedural knowledge of the audit’s subject areas. Auditors should also work in cooperation and partnership with parties being audited.

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