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

Michael Ferrante
President, Quality and Compliance Associates LLC

Mr. Ferrante is President of Quality and Compliance Associates LLC and has over 40 years experience in the pharmaceutical and biotechnology fields. This experience encompasses quality systems, laboratories, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, and facilities covering all dosage forms.

During his career, Mr. Ferrante has successfully dealt with over 100 inspections by regulatory agencies, resolved warning letters, prepared and controlled compliance plans at both a site and corporate level. These interactions have occurred both domestically (US) and internationally, since he has dealt in global operations in countries such as Australia, Canada, the Netherlands, Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, the Czech Republic, India, China, Malaysia, and Thailand.

He has held middle to senior management positions in startup to Fortune 100 companies up to the level of VP of Quality Systems and Compliance. Mr. Ferrante has been asked to give presentations on a number of regulatory and quality topics by the American Society for Quality, the Parenteral Drug Association, International Society of Pharmaceutical Engineers, and the Institute for Validation Technology. He has published articles in the Journal of Validation and Journal of Compliance.

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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