Effective Internal Audit Program

Internal Audit is an essential part of any effective quality system. Most notably, it is an incredibly powerful tool to identify gaps in compliance programs. A well designed internal audit program can be an effective instrument in understanding, communicating, and reducing compliance risk. However, there are reports that up to 75% of companies conduct audits only because they are mandated by the FDA. In spite of having an internal audit program in place, management is frequently surprised when they receive a 483, Warning Letter, or even a Consent Decree. Businesses must start viewing internal audit programs as an integral part of their quality culture and stop seeing it as a non-value added activity which only leads to obscurity, bureaucracy, and creating cumbersome processes. Without an effective audit program, management will be forced to face the risks in delivering quality medical devices to their customers blindly. Is your audit program and corrective action systems effectively and efficiently identifying and mitigating compliance risk? This webinar will help you identify red-flags as you endeavor to create a fool proof system. How do you make your audit program meaningful? We will show you how to make an internal audit program a key tool in maintaining and improving your Quality System. Being blind to compliance risks within their own organization is no excuse when your firm gets a 483 or Warning Letter. Don’t take unacceptable risks anymore. Let’s use effective internal audits to reduce your quality and compliance risks and ensure compliance.

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 Should Attend:

• Compliance Managers
• Quality Managers
• Compliance Directors
• Quality Directors
• Regulatory Affairs Professionals
• Auditors
• Compliance Specialists
• Professionals performing due diligence and management review

Course Director: 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.