GENERAL QUALITY SYSTEM REQUIREMENTS SOP GROUP

GENERAL QUALITY SYSTEM REQUIREMENTS SOP GROUP

This SOP group describes procedures necessary for a compliant Quality System including how to plan for a FDA audit and respond to 483's and warning letters.


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This SOP group describes procedures necessary for a compliant Quality System including how to survive a FDA audit and respond to 483's and warning letters.

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

 

$650.00
The QSM establishes the general policies governing the COMPANY Quality System and establishes a systematic approach to the implementation of policies and plans.(23 pages)
$150.00
This SOP establishes a method for management to review the Quality System to ensure its continuing suitability and effectiveness. (4 pages)
$100.00
This SOP describes the process for identifying, providing for, and documentating personnel training. (8 pages)
$100.00
This SOP describes the internal Quality System audit process. It's purpose is to determine whether policies and procedures are properly implemented and effective. (6 pages + 3 report forms)
$125.00

This SOP explains how to prepare for and describes procedures to be followed by personnel who are involved in a FDA regulatory inspection. Front and back room operation is explained. Procedure explains best practices to create a written response to 483 observations received. SOP is based on personal experiences with FDA audits. A 3 page checklist for inspection preparation is included(13 pages +1 form)

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

$150.00
This 30 page internal audit workbook covers all parts of the Quality System in detail. Each audit question includes a reference to the appropriate QRS section. If your organization passes this audit you can be confident your Quality System will pass FDA scrutiny.
$150.00