Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News


FDA Compliance

Quality System Inspection Technique (QSIT) Course Available

Survive an FDA inspection

Published: Tuesday, August 30, 2011 - 12:37

(STAT A MATRIX: Edison, NJ) -- Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, “FDA’s Quality System Inspection Technique (QSIT),” is intended to facilitate manufacturer compliance with the FDA’s Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.

Understand exactly what FDA investigators will look for during establishment inspections that focus on the specific subsystems of management controls, design controls, production and process controls (P&PC), and corrective and preventive actions (CAPA). Class discussions cover guidelines for the preparation and management of quality system inspections conducted by the FDA so you will be ready for your inspection.

Click here to see upcoming dates for this course.

For a complete week of FDA regulatory training, combine this one-day program with the two-day programs: Understanding FDA's Medical Device Quality System Requirements and Understanding an ISO 13485 Quality Management System. To learn more about this course combo, select course code ZFF or click here.


About The Author

Oriel STAT A MATRIX’s picture


Since 1968, Oriel STAT A MATRIX has delivered billions of dollars of increased profitability by helping organizations drive revenue and reduce costs. Oriel STAT A MATRIX is a global leader in consulting and training related to performance improvement and regulatory compliance. It has helped hundreds of companies throughout the world effectively develop the potential from within their organizations to successfully integrate and deploy performance improvement principles and practices, and to meet organizational, regulatory, and strategic goals.