CAPA SOP GROUP

CAPA SOP GROUP

This SOP group comprises a compliant CAPA program including SOP's for recalls, MDR's and post distribution product monitoring.


Display per page
Sort by

This SOP group contains procedures for a compliant CAPA program including recalls, MDR's and post distribution product monitoring.

Select this item to order all titles below at a reduced price.

$750.00

This SOP describes and controls the complete CAPA procedure necessary to satisfy FDA requirements. It covers complaint evaluation (what is a complaint?), process nonconformities, MDR evaluation, trending, etc. A Visio flowchart clarifies this complex process (13 pages + 1 report form).

Webinar slides which explain the SOP and the context of the SOP are included. These could be used for training.

$150.00
This SOP explains, describes and controls the Corrections and Removals Process including criteria for when to notify FDA and the differences between a C&R and a Recall. (4 pages)
$125.00
This SOP describes and controls the Recall Procedure including criteria and methods for FDA and customer notifications and effectiveness checking(7 pages).
$125.00
This SOP describes and controls the Complaint Trend Analysis process including steps to be taken when a trend is discovered.
$125.00

This SOP describes criteria and procedures for MDR reporting to FDA (5 pages).

Webinar slides which explain the SOP and the context of the SOP are included. These could be used for training.

$150.00
This SOP describes detailed FDA compliant procedures for a company to follow in investigating product problems following product release. A Investigation Report form and Corrective Action Plan form are included. (5 pages +2 forms).
$125.00
This SOP includes a Task List form to guide the process.(6 pages +form)
$125.00