Dan O’Leary will present a webinar for Compliance Panel on a Unified Approach to Complaints, Servicing, and FDA Reporting. Go to http://www.globalcompliancepanel.com for registration information.
This course provides the attendees with the information to implement an effective system for managing and reporting adverse events. We break down the regulatory requirements into plain English, and describe them using common quality tools such as flow diagrams and fault tree analysis. This approach helps you understand the essential parts of the regulations.
We provide complete descriptions of the interlocking systems that the FDA requires you to implement. These systems include:
- Complaint Management
- Medical Device Reporting
- Corrections and Removals Management and Reporting
- Corrective Actions
- Corrective Action Statistical Analysis
- Risk Management
- Service Reports
- Service Report Statistical Analysis
These requirements are spread across multiple parts of the FDA regulations, so they are not always implemented in unison. The presentation unites the systems to make their implementation easier and more effective.
You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, what records you must keep, and when you must report to the FDA.
You will see statistical techniques that can be used to analyze corrective actions and service reports. These include histograms, scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams.
Because these regulations may also span your organizational structure, this webinar is especially suited for cross functional and cross discipline teams.