“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