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QMS TRAINING for the Medical Device Industry

April 28-29, 2010
Tampa, Florida



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   GENERAL INFORMATION

 


COURSE EXPECTATIONS:

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, are often required to comply with ISO 13485 requirements. QARA Compliance Connection's 2-Day QMS Requirements Training course was designed to provide personnel with an in-depth knowledge and understanding of the FDA QSR and ISO 13485 quality management system requirements in order to meet domestic and international requirements for quality.

Interactive discussion and group exercises have been incorporated into the training program in order to provide participants with the opportunity to apply concepts learned to real-world situations, thereby resulting in training that is both comprehensive in theory and application.

This course is ideal for those individuals responsible for developing, implementing, complying, managing and auditing an organization's QMS.

COURSE HIGHLIGHTS:

Basic Review of US, Canadian and European Regulatory Requirements
An Introduction to QMS Standards and Regulations
ISO's Process Approach to QMS Compliance
FDA's Quality System Inspection Technique
Reasons and Benefits of Compliance
Key Terms and Definitions
In-Depth Review of QMS Requirements
How to Conduct a Risk Assessment
Methods for Conducting Root Cause Analysis and Determining Effective CAPA
Typical FDA 483 Observations/ISO 3rd Party Nonconformances
Typical Auditor/Inspector Questions
Tips for Compliance with the Requirements
FDA Enforcement Options/Actions and Examples
Course Binder Complete with Slides, Templates, Sample Forms, etc.
Certificate of Completion

INSTRUCTOR:

The seminar will be lead by Marie Teixeira, a leading quality assurance and regulatory affairs compliance expert with over 20 years experience. Ms. Teixeira holds a BS degree in Industrial Engineering and Operations Research and is an ASQ Certified Quality Manager, ASQ Certified Quality Engineer, and RAB Quality Management System Principal Auditor. Ms. Teixeira was also an active member of an international task force CEN/TC257/SC-DETG10 - whose objective was to standardize medical device nonmenclature. Ms. Teixeira co-authored a book titled "Design Controls for the Medical Device Industry" as well as published various handbooks and quality system related training modules.

If you're looking for a course taught by someone who has lived and breathed quality management systems for over twenty years, this course is for you. Ms. Teixeira understands compliance from the manufacturer's perspective as well as from the auditor's perspective. She has been responsible for successfully implementing and maintaining quality management systems to FDA, Canada and European requirements for numerous companies and been on the receiving end of many FDA inspections and 3rd party Notified Body audits. Being an RABQSA Registered Principal Auditor, she has also performed countless audits to FDA's QSR and ISO's 13485 quality management system standard.

TRAINING VENUE:

The location of the training shall be at the Hilton Tampa Airport Westshore in Tampa, Florida. QARA Compliance Connection has secured a reduced hotel room rate. Hotel reservations can be made directly via the website listed below. Be sure to make your reservations early!

The contact information for the hotel is as follows:

Hilton Tampa Airport Westshore
2225 North Lois Avenue
Tampa, FL 33607
Tel: 813-874-5008
Fax: 813-872-0603
Web: http://www.hilton.com/en/hi/groups/personalized/TPAAHHF-QARA-20100428/index.jhtml?WT.mc_id=POG



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