Don't Miss Out -- Register Now for QARACC's Upcoming 'QMS Requirements Training' Seminar in Tampa, Florida

Tampa, FL (PRWEB) August 14, 2007 -- QARA Compliance Connection, Inc. is offering a "QMS Requirements Training" course on October 17th and 18th, 2007 at the Westin Tampa Harbour Island Hotel.

Manufacturers of medical devices looking to sell product in the U.S. are mandated to implement and comply with the FDA's Quality System Regulation (QSR) codified under 21 CFR Part 820. Further, manufacturers looking to remain competitive and/or expand their distribution into other countries such as Europe and Canada, may be required to comply with ISO 13485 requirements as well. This 2-day training course will provide medical professionals with an in-depth knowledge and perspective of the FDA QSR and ISO 13485 quality management system requirements. The requirements will be presented using an FDA QSR subpart format.

Course Highlight:

- QMS Introduction

- Benefits of Compliance

- ISO's Process Approach

- FDA's Quality System Inspection Technique (QSIT)

- Key Terms & Definitions

- In-Depth Requirements Review

- FDA 483 Observation Examples

- General Auditor/Investigator Questions

- Interactive Discussion & Real World Application Through Mock Exercises

- Tips for Compliance

- FDA Enforcement Actions

- and more

Marie Teixeira, President of QARACC, was quoted as saying, "This program is unique in that it covers both sets of requirements and presents information in a manner that facilitates learning. Interactive discussion and mock exercises have been incorporated into the program to assist participants in applying the requirements to their respective organizations."

This seminar is ideal for those individuals responsible for developing, implementing, complying, managing and auditing company's quality management systems.

For more information, contact QARA Compliance Connection, Inc at:

Tel: (813) 784-8457

Email: info @ qaracc.com

Web: www.qaracc.com/seminars.html

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