Mitigating Your Risk of getting 483s and Warning Letters

Almost daily we hear and read about companies receiving 483s, Warning Letters, and even Consent Decrees. Often executive management is surprised by these events. These companies face not only embarrassing media coverage but also costly investigations and corrective/preventive action. Quality and Compliance problems can seriously impact customer satisfaction, sales, market share, and ultimately business results.

This webinar will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. You will learn how to communicate effectively to ensure management commitment and resources for continuous improvement.

In some cases, management can face personal civil or criminal charges for failure to address issues.

• They did not get the data or information identifying quality and compliance issues. The data did not clearly articulate a need or sense of urgency for improvement.
• They got the information but did not effectively prioritize, resource, and implement corrective actions.
• They got the information but company culture did not create an appropriate environment to clearly identify, escalate, and mitigate quality and compliance issues.

A well designed Quality Management System and program of compliance can help companies prevent issues resulting in improved product quality, customer satisfaction, and business success.

• Techniques such as process monitoring, internal audit, 3rd party audit, and due diligence to monitor processes and identify areas of risk
• Using metrics and dashboards to clearly articulate quality, process performance, and results
• Warning flags that indicate a pattern of compliance issues or recidivist tendencies
• Using Management Review to clearly articulate, prioritize, and escalate risks
• How a culture of quality and compliance can seriously impact a companys ability to clearly identify and reduce compliance risk
• How to prioritize and plan improvements to quality and compliance results?
• Monitoring and Controlling progress over time

This webcast will be of a valuable assistance to the below audience.

• Complaint Specialists and Managers
• Quality and Compliance managers or directors for Medical Device companies
• Compliance personnel performing audits, due diligence, and management review
• General Managers wanting to learn how to understand, interpret, and use information from management review to improve business results