Internal Quality Audit: Identifying Corrective and Preventive Actions

Why Should You Attend:

Conducting internal quality audits and using the findings to make needed improvements to the quality system are regulatory requirements. Case studies illustrate typical audit findings and how they can be addressed by the audit program. Internal audits are designed to detect nonconformances that need corrective action and potential problems that require preventive action. Significant audit finding should be captured in the CAPA system which also provides a mechanism for resolving issues and tracking outcomes. Well trained auditors are an essential part of the quality system, and provide assurance that the quality system is being maintained. The internal audit program, consistently applied, provides the company with an increased measure of product quality.

Learning Objectives:

• Understanding regulatory requirements
• Committing adequate resources to the internal audit program
• Maintaining separation and cooperation between operations and quality auditors
• Opening CAPAs on significant issues
• Tracking problem resolutions and outcomes

Areas Covered in the Webinar:

• Why we perform internal audits
• Practical guidelines in planning internal audits
• Auditor qualifications and training
• Effective quality audits
• Audit reports and files
• Communicating audit findings
• Opening CAPAs
• Case studies
• Audit Checklist

Who Will Benefit:

• Executive Management
• Internal Quality Auditors
• Quality Managers
• Regulatory Affairs Managers
• Marketing Managers
• R & D Managers
• Program Managers
• Project Managers
• Product Development and Engineering Managers

Instructor Profile:

Ronald Schoengold, has been an active contributor to the medical device, pharmaceutical and biomedical environment for over 45 years. As a consultant to both large and small companies, he offers expert advice on quality systems, regulatory submissions and resolution of regulatory and quality problems. He is also an experienced auditor in clinical research, supply chain and manufacturing (GMPs). Ron is certified in regulatory affairs and has a proven record of accomplishment for integrating quality and regulatory requirements with technical, organizational and business development needs. He offers critical advice on the effective commercialization, support and maintenance of medical products and services and is an advisor to the National Institutes of Health, Commercialization Assistance Program, assisting companies awarded SBIR grants. Ron has published, presented or contributed to more than 16 scientific publications including a book chapter on point-of-care testing. He holds 8 patents related to point-of-care diagnostics.

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