The duty of every competent regulatory manager and quality manager is to use the QSIT
questions as well as the related regulations to see how their QMS is complying.
determines compliance by auditing these subsystems and related records.
Best practices for determining the number of records to inspect, when an FDA investigator asks for records, the number reviewed is determined by a sampling plan in QSIT
When FDA field inspectors show up at the front door of your medical product manufacturing company -- searching for Quality Systems Regulation (QSR) and QSIT
violations -- what do you do when they find something wrong?
What the FDA wants, despite being described in the QSIT
, is still a mystery to many.
Tim Wells , President, QualityHub; former Team Leader for the QSIT
Project, CDRH, FDA
The first presentation in this session is "How local manufacturers establish concrete compliance evidence to satisfy FDA QSIT
inspection" (Scott Yu, an independent regulatory consultant).
15) According to FDA's QSIT
guide, specific actions to consider when reviewing the adequacy of a product or process change include "changes in component supplier, training, changes to acceptance activities, field action [i.
The GPMG ISO 13485 Quality System was originally developed to expedite factory relocation projects and to rapidly address quality system gaps identified during FDA QSIT
100, cGMP, ISO 9000/ 13485/14971, QSIT
and automated systems for quality, has CAPA evolved during the past decade, and are we moving in the right direction?
The 2007 Q3 QSIT
findings also showed that approximately 60 percent of companies still emphasize stock options in their programs.
In addition to decreasing turnover, the Q4 QSIT
revealed that technology companies continue to seek lower costs by trimming their workforce.