Course “Device Corrections and Removals” has been pre-approved by RAPS as eligible for up to 1.5 credits for recertification CCR participants to fully complete.
Summary: If you see a problem with a device that was sent to you, arrange for customers to your business. Do you report to the FDA?
If you send a letter to customers saying, “We have a problem, but do not worry, we will fix it for you”, you can call the correctional process and evening. Under Section 806 of the FDA regulations, the need to report these facts to the FDA.
Under certain circumstances, you may have to report, but you can register your decision. You need to make sure that you know when to report and when the recording is enough.
Why you should attend: An FDA inspection and final corrections to be removed for analysis. Inspectors regularly check the specific actions that will monitor your site and usually get a copy of the letter sent to the customer. If you send a letter of notification to their customers’ problems, which will almost certainly be a competitor copy will be sent to the FDA. If you do not inform the FDA inspectors asked for your records to document the reason for not reporting.
This seminar explains the recovery and disposal of their obligations in accordance with Section 806. You will learn:
Requirements of Article 806 covers difference between statements and notes
The difference between correction and recession and how to report
Exceptions to Section 806 and how to apply them to make decisions about reporting
What inspectors will ask tested QSIT
What to look for in an effective program and how to ensure that your program makes the grade
Results from a warning letter and how you can avoid some of the same problems
Relationships and the design changes that may need to update the 510 (k)
The area covered in Session
The basic requirements of Article 806
When the report
Exceptions may occur
Reporting under Section 803 – Report of Medical Device
Reporting under Section 1004 – repurchase, toolmaking, or replacement of electronic products
Reporting and Weather
Admission requirements are not reported
Hope inspection QSIT
Elements of a stable system
How to check the system to maintain
Design changes and the potential 510 (k) submission
The current rules
Who will benefit:
This seminar is for people who are involved in the complaint, risk management, customer communications, and regulatory affairs.
People in the following roles can especially benefit from the knowledge of the seminar:
Specialization in Risk Management
Complaints Manager and Specialist
General / Corporate Counsel
Controls Professionals Legislative Affairs /
And is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on skills and strategies for managing system operations analysis. And has over 30 years experience in quality, operations and program management set as flight, defense, medical equipment and clinical laboratory industry. Has a Master of Mathematics; are ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt, and is certified by APICS in Resource Management.