This FDA inspection training webinar provides practical advice on the FDA requirements for complaints. It explores the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side we explain the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints.
As an added bonus, the webinar will include the newly proposed regulations for electronic filing of MDRs, the eMDR program
Why you should Attend:
The “new” FDA, under Dr. Hamburg, is increasing enforcement activities. The FDA districts are increasing the inspection frequency, meaning you are more likely to be inspected. The new rules on Warning Letters means you are more likely to be cited based on the observations from an inspection. The very best approach is to ensure you understand the requirements and have them fully implemented. You must understand the full set of regulations so you can cover all 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 & 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?
This FDA compliance 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.
This compliance training 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.
As these requirements are spread across multiple parts of the FDA regulations, 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.
Areas Covered in the seminar:
- 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
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. You will see the regulations transposed to plain English, which will help you formulate your approach to full compliance. In addition, the presentation provides technical details, using common quality tools, to help you develop your procedures.
Who will benefit:
This seminar is designed for quality, regulatory, service, sales, and design people who may become involved in adverse events. In addition, Sales and Service employees are often the first to become aware of post-production problems. Design employees are often the first to recognize the need for field action. The FDA has stringent requirements for reporting, so people who may impact the timeline need to understand the requirements.
Attendees should understand service, problem reporting, corrective action, and field action processes. In addition, people in Sales or Service must recognize and report complaints or potential MDRs. Because of the cross functional and cross discipline aspects, this is an ideal opportunity for team attendance. You need to ensure that all parties get the same message. People in the following roles can especially benefit from the knowledge in this webinar:
- Quality Engineers
- Regulatory Managers
- Regulatory Specialists
- 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 analytic skills and a systems approach to operations management. Dan 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 Masters 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.
