A Unified Approach to Complaints, Servicing, and FDA Reporting

This webinar will provide practical information on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. It will explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side, the course will detail the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints. This webinar will minimize the use of regulatory language and easily illustrate how participants can implement an effective and unified system. As an added bonus, the webinar will include information on the UDI rule and the eMDR rule.

Why Should You Attend:

This course will provide attendees with the information needed to implement an effective system for managing and reporting adverse events. The webinar instructor will break down the regulatory requirements in a simple format, and describe them using common quality tools such as flow diagrams and fault tree analysis for better comprehension of the regulations.

Further, the instructor will 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 will unite the systems to make their implementation easier and more effective. Participants 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.
• Other key illustrations include 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.

Learning Objectives:

• The integration of multiple processes relating to adverse events can significantly improve a company’s regulatory compliance as well as reduce total cost. Participants will learn how to implement this integrated approach.
• The regulations will be transposed to a simpler language, which will help you formulate an approach towards full compliance. In addition, the presentation will provide technical details, using common quality tools, to help attendees develop their procedures.

Areas Covered in the Webinar:

Complaint Management

• Understanding complaints in QSR - it is more than you think
• When complaints should be evaluated
• When complaint evaluation is mandatory
• MDRs as a special kind of complaint
• Record keeping for complaint management
• Medical Device Reporting for Manufacturers
• When did your company become aware?
• When is an MDR required?
• When do you have to file a 30 day report?
• When do you have to file a 5-day report?
• Baseline and annual reports - FDA makes a mess of the regulations
• When is an MDR also a complaint?
• Understand the proposed eMDR requirements and its impact on you
• Corrections and Removals Management and Reporting
• When did you decide to initiate action?
• Understand the required records for field actions
• Distinguish between a Correction and a Removal
• When is a report required for a Correction or Removal?
• When do you have to report the same event as an MDR and a Correction or Removal?

Corrective Actions

• Distinguish between Corrections and Corrective Actions in Part 820
• Distinguish between Part 820 Corrections and Part 806 Corrections
• Understand the role of Design Change (820.30) in Corrections
• Evaluating Design Change for revised 510(k) submissions

Corrective Action Statistical Analysis

• Understand the requirement for statistical analysis
• Apply quality tools to conduct the statistical analysis
• Defining statistical methods in 820.250

Risk Management

• Integrating the information into your ISO 14971 risk management system
• Maintaining the risk management file in the post-production phase

Service Reports

• Understand the required records for service reports

Service Report Statistical Analysis

• Understand the requirement for statistical analysis
• Apply quality tools to conduct the statistical analysis
• Defining statistical methods in 820.250

Who Will Benefit:

• Quality engineers
• Quality managers
• Regulatory specialists
• Regulatory managers
• Compliance specialists
• CAPA specialists
• Sales managers
• Service engineers
• Service supervisors
• Service managers
• Manufacturing engineers
• Design engineers
• Engineers involved in managing design changes
• Engineers involved in developing field modifications