Effective Internal Audit Program

“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. A well designed audit program can be an effective tool in understanding, communicating, and reducing compliance risk.

However, estimates indicate that up to 75% of 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. In spite of having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree.

Without an effective audit program, management is blind to many of the risks they face in delivering quality medical devices to their customers. We will discuss red-flags that indicate your audit and corrective action systems are not effectively and efficiently identifying and mitigating compliance risk. We will cover how to make your audit program meaningful and a key tool in maintaining and improving your Quality System.”

Many companies are surprised when they get a 483 or Warning Letter. They have been blind to compliance risks within their own organization. This webinar can help you understand how to use Internal Audit as a powerful tool to understand, communicate, and mitigate compliance and quality issues. You will learn how to effectively and efficiently develop your audit program and reduce your quality and compliance risks. You will discover some of the “red flags” that indicate your company is taking unacceptable risks.

Areas Covered in the Session :
Risk Assessment
Developing a Structured Program
How to develop an Audit Hierarchy
Ensure Your Audit Staff is Well Trained to Proactively Identify, Communicate, Escalate Issues
Culture of Quality
Prioritize, Resources, and Implement Corrective Actions
Monitoring and Communicating Risk
Residual Risk
Red Flags

Who Will Benefit:
Compliance Managers
Quality Managers
Compliance Directors
Quality Directors
Regulatory AffairsProfessionals
Compliance Specialists
Professionals performing due diligence and management review

Susanne Manz

Susanne Manz 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. She 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance