Internal Audit For Medical Device Companies - How To Make Your Audit Program More Effective

Why Should You Attend:

Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk. Many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value-added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree.

In this webinar, we will discuss:

• Failures of internal audit
• Red flags indicating your program is not effective
• Identify weaknesses in your internal audit program
• Risk Analysis techniques
• Audit Program Structure
• Improvements for your Audit Program

Areas Covered in the Webinar:

This 90-minute webinar will include:

• Regulatory requirements
• Using a structured program to identify areas of risk leading to an effective audit strategy.
• How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review.
• How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues.
• How a culture of quality and compliance can encourage clear and transparent communication of risk.
• How to prioritize, resource, and implement corrective actions.
• Tools for monitoring and communicating risk and improvement over time.
• How to identify residual risk.
• Monitoring and Controlling progress over time.
• Signs that your company culture is taking unnecessary compliance or quality risk.
• How to ensure management gets valuable information from your audit program.
• How to prioritize, resource, and implement corrective actions.
• Tools for monitoring and communicating risk and improvement over time.

Internal audit should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance and quality risks. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.

Who Will Benefit:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Auditors
• Auditor Managers
• Supplier Auditors
• Training Specialists
• CAPA Specialists
• Quality/Compliance managers or directors for Medical Device companies
• General Managers wanting to learn how to Management Review and expectations

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

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