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Mitigating Your Risk of getting 483s and Warning Letters

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Course Description:

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.

Why should you Attend?

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.

So why is management surprised when they get a 483, warning letter, or consent decree?
  • 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.

Areas Covered:

This 90-minute webcast will focus on how to identify, analyze, report, and reduce compliance risk. Topics to be covered include:
  • 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

Who will benefit?

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

Registration Options

Avail 12 months unlimited access for a single user.

Material shipped within 15 days post webinar completion & get life time access for unlimited participants.

Speaker Details

Susanne Manz

Susanne Manz

Medical Device Consultant

Susanne Manz, MBA, MBB, RAC, CQA 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

Refund Policy

Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).