Regulatory Reporting: Building Systems and Processes to Ensure Compliance

This regulatory reporting webinar will discuss the importance and characteristics of a regulatory reporting system. It will also explain how to create processes to work seamlessly with it along with the planning and designing the system to meet the requirements of complaint and adverse event reporting accurately and timely.

Why Should You Attend:

One of the most challenging areas for medical device and IVD companies to manage is regulatory reporting. Regulatory agencies around the world require manufacturers to have systems in place that can quickly and accurately assess whether a complaint is routine or an adverse event. Further, manufacturers are expected to track issues with their devices over time to determine if there is a systemic problem requiring market withdrawal or a formal recall. The systems that manufacturers put in place to handle complaints and assess them for potential regulatory review have to be robust and scalable.

This webinar will go through the requirements and give advice on how to plan and design systems to meet the requirements for regulatory reporting. You will learn concepts and ideas based on real-world experiences that can help them design and implement systems that will make them more effective.

Areas Covered in the Webinar:

• Regulatory reporting requirements for key markets.
• Complaint handling processes and training.
• Key considerations (global markets, distributors, role of authorized reps and notified bodies).
• Regulatory reporting systems - reporting, monitoring, recalls.

Who Will Benefit:

• Customer Service and Support Managers
• Quality Assurance Managers
• Regulatory Affairs Managers
• Field Application Specialist