Transforming Your Quality System from Reactive to Proactive

Predictive Compliance 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.

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

So why is management surprised when they get a 483, warning letter, or consent decree?
They didn’t get the data/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.

Areas Covered in the Session : 

• Techniques such as process monitoring, internal audit, 3rd party audit, and due diligence to monitor processes and identify areas of risk.
• Using metrics/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 areas of risk.
• How a culture of quality and compliance can seriously impact a company’s 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.

Who Should Attend:

• Quality Department
• Compliance Department
• 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

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.