Overview: The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device. The manufacturer must also compile records of the production history of the device. These two sets of records (DMR & DHR) are complimentary.
In addition, the manufacturer maintains two more sets of documents, the Design History File (DHF) and the Quality System Record (QSR). This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA's thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm's experience. Why should you attend: An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures.
Much of the evidence is in the four records we discuss in the webinar. If you determine what you keep in each record and then follow your decision, you will have the evidence that you need. Moreover, a well organized set of records will help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action. Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!
Can you list the kinds of records that belong in the Design History File (DHF)?
Can your team relate the component specifications in the DMR to the Purchasing Data you use to obtain the components?
Does your team know the records you must keep when you verify the component at receiving?
Does you team know which of these records must go into the DHR?
Can your team list the activities that require a designated individual?
Do you have quality records that designate the individual and demonstrate training to perform the assigned responsibility?
Can you list the activities and the designated individuals in your company?
Can your team assure that the designated individual, not somebody else, performed the activity before you released the product for distribution?
Some information could be in the DMR or the QSR. Does you team know how to make the decision?
Areas Covered in the Session:
The FDA's QSR
The source of the requirements
The QSR Manual
OMB information collection
Design History File (DHF)
Quality System Record (QSR)
Device Master Record (DMR)
Linkage to Design Controls
Lessons for Implementation
Device History Record (DHR)
Linkage to the DMR
Lessons for Implementation
State the four major records required in FDA's QSR
Describe the contents of the Design History File (DHF)
Explain the source of the Device Master Record (DMR)
Describe how the Device History Record (DHR) relates to the DMR
State the required content of the Quality system Record (QSR)
Explain the difference between information if the DMR and the QSR
Understand the concept of a "designated individual" and the qualifications