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QMS TRAINING for the Medical Device Industry

October 17-18, 2007
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, may be required to comply with ISO 13485 requirements. This two-day course will provide personnel with an in-depth knowledge and perspective of the FDA QSR and ISO 13485 quality management system requirements. The requirements are presented using the QSR subpart format. This course is ideal for those individuals responsible for developing, implementing, complying, managing and auditing the organizations QMS. Interactive discussion and mock exercises will assist participants in understanding and applying the requirements.

COURSE HIGHLIGHTS:

QMS Introduction, Benefits of Compliance, ISO's Process Approach, FDA's Quality System Inspection Technique (QSIT), Key Terms and Definitions, In-Depth Requirements Review, FDA 483 Observation Examples, General Auditor/Inspector Questions, Interactive Discussion and Real World Application through Mock Exercises, Tips for Compliance, FDA Enforcement Actions, 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 Lead 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 and is currently serving on an ASQ QAD/RAB committee. Ms. Teixeira recently co-authored a book titled "Design Controls for the Medical Device Industry" published through Marcel Dekker

TRAINING VENUE:

The training will be held at the Westin Tampa Harbour Island, Tampa, Florida. The Westin Harbour Island is just 10 miles from Tampa International Airport and a complimentary shuttle is available to and from the airport. When making reservations be sure to ask for the discount rate associated with the QMS Training being conducted by QARA Compliance Connection, Inc. This is peak season so be sure to make your reservations early!

The contact information for the hotel is as follows:

Westin Tampa Harbour Island
725 South Harbour Island Blvd
Tampa, FL 33602
Tel: (813) 229-5011
Fax: (813) 229-5022



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