Webinar on Effective Internal Audit Program

Website https://compliancetrainings.com/product/effective-internal-audit-program/ | Edit Freely

Category FDA Compliance, Food, Drugs & Biologics, Medical Devices

Deadline: January 24, 2017 | Date: January 24, 2017

Venue/Country: Online, Canada

Updated: 2016-12-19 22:36:52 (GMT+9)

Call For Papers - CFP

“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

Auditors

Compliance Specialists

Professionals performing due diligence and management review