Design Control, Software & Regulatory Consulting
FDA & ISO
Noblitt & Rueland: FDA & GMP, Design Control & Medical Device Software Consulting and Training Services


FDA Quality System Inspection Technique (QSIT) '99

Training Seminar


Overview:

FDA has introduced the Quality System Inspection Technique (QSIT) as the new method for performing CGMP/QSR inspections of medical device manufacturers. QSIT applies to all aspects of an FDA inspection to 21 CFR Part 820. This seminar provides detailed training on QSIT to allow medical device manufactures to prepare to avoid legal and regulatory compliance concerns while presenting efficient methods to handle this new FDA inspection strategy. The course is essential for RA/QA executives & management who are responsible to ensure that the implemented quality system matches FDA QSIT expectations for the identified seven (7) subsystems. It is also highly recommended for Executive Management, R&D, Manufacturing and Quality Systems personnel including anyone responsible for any activities occurring within one of the seven subsystems (see outline below).

What you will learn:

Benefits of Attending:

Abbreviated Outline:

Speakers: Ray Pizinger

Special Guest Speaker(s):

Denise Dion, Expert Investigator, Department of Emergency & Investigational Operations, U.S. Food and Drug Administration. As one of the authors of the the recent Guide to Quality System Inspections and the FDA Investigators QSIT training CD-Rom, Ms. Dion will discuss the FDA's QSIT implementation plans, enforcement activities, training plans, international QSIT inspection plans, QSIT inspection results to date, and she will perform a demonstration of the FDA's QSIT investigators training CD Rom.

Vickie Anderson, Investigator, Los Angeles District, has been invited to discuss the agencies finding and her first hand experience performing QSIT inspections. Vickie was one of a handful (12) of investigators choosen worldwide to perform QSIT inspections during FDA's QSIT pilot program. Vickie has been performing QSIT inspections as part of this pilout program since early this year.


Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!


Autumn is a gorgeous and popular meeting time in San Francisco!
Be sure to reserve your space and room early! A small block is being held! Rooms will sell-out!


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