A Unified Approach to Complaints, Servicing, and FDA Reporting

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

Instructor Profile:

Daniel O'Leary is the president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytical skills and a systems approach to operations management. Mr. O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s degree in mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and is certified by APICS in resource management.

Topic Background:

The FDA continues to focus on post-market surveillance. One of the leading Warning Letter citations is failure to implement an effective complaint management system. In addition, complaints can lead to MDRs, Corrections, and Removals. Warning Letters often cite failures, or even no implementation, of these other systems. Firms don’t always create a unified approach, because these related systems are not in Part 820, QSR. As a result, they may be misunderstood or ignored.

The best approach to an FDA inspection is to understand and implement the regulations. You must understand the full set of regulations so you can cover all the requirements. The FDA has stringent requirements for reporting, so people who may impact the timeline need to understand the requirements. This webinar will give you the tools and techniques you will need to avoid receiving an FDA 483 or Warning Letter in this area.

If your Quality Management System (QMS), through its documented procedures, cannot answer these question quickly, and without hesitation, then you, and your team need to attend this webinar:

• Do you know when a complaint should be reported as an MDR?
• Can you distinguish between 5-day and 30-day MDR reports?
• Do you know the required records for field actions involving changes to a medical device?
• Does your procedure clearly identify when field actions must be reported to the FDA?
• Do you understand how a remedial action in an MDR relates to Corrections and Removals reporting?
• Do you maintain the required records for field actions?
• Do you maintain the required records for service actions?
• Do you have systems in place for statistical analysis of service reports?
• Can your sales and service people recognize a potential MDR event and report it correctly?
• Do you have a plan to implement UDI?
• Are you preparing for eMDR?

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