Webinar: Complaint Handling, Regulatory Reporting & Investigation for the Medical Device Industry © 2006, Sparta Systems, Inc.

Agenda:

1. Presentation: This Webinar will discuss best practices for the recording, investigation, resolution and reporting of complaints in accordance with good manufacturing practices (GMPs) and regulatory compliance mandates, as well as how implementing TrackWise for Complaint Management, Investigations, and Regulatory Reporting, can reduce complaint investigation times and assessment cycle times, as well as contribute to cost reductions

2. A live TrackWise demonstration will show attendees how TrackWise:

• Streamlines the complaint intake process using a centralized web-based tool
• Automatically routes complaint records to the appropriate assessment and investigation facilities
• Streamlines the product return, investigation, and root cause analysis process
• Improves cycle times for review and approval processes
• Ensures notification of potential field actions and recalls based on pre-determined       business rules
• Issues regulatory reports, such as MedWatch, Vigilance, and others
• Leverages key data through querying and reporting to identify developing trends and recurring issues