The CFR regulations described with respect to Management Responsibility are:
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>>
The FDA preannouncement call will request a copy of:
* the firm's [[quality policy system procedure|CFR 21-820.20e - Quality System Procedures]]
* The [[Quality Manual]]
* The [[Quality Plan]]

!FDA Inspection
* The investigators will review the written [[Quality Policy]] and will assess it to ensure that it defines tthe firm's overall quality intention
* The investigators will determine whether the firms [[Management with executive responsibility]] ensures that the quality policy is understood at all levels of the organization.
* Investigators will determine whethere management reviews and quality audits are being conducted in correspondence with written procedures.
* They will evaluate the firms [[Quality Plan]] to determine if the firm's quality practices, resources and activities are relevant and specific to the regulated medical devices that are manufactured.

Each manufacturer must prepare and implement all activities the applicable requirements of the [[Quality System Regulation]] that are necceary to assure that the device, the design process, the manufacturing process and all related activities conform to approved specifications.

!Management Representative
The FDA expects that a firm has a documented ''management representative'' that has review and approval responsibility for appropriate milestones in the quality system. Investigators will assess a firms:
* Organizational Chart
* Quality Manual
* [[Design Control Activities]]
* Complaint Procedures
* Medical Device reporting procedures
* [[Quality Audit Procedure]] and schedule
* Quality reaudits, audit reports and corrective and preventive actions.

The management representatives 'fingerprints' should be all over these activities.

<<tiddler [[CFR 21-820.20 - Management Control Flowchart]]>>
bag
fda_public
created
Sun, 01 Jul 2012 14:36:37 GMT
creator
dirkjan
modified
Sun, 01 Jul 2012 14:36:37 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.20
FDA
Term
creator
dirkjan