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QMS TRAINING for the Medical Device Industry
October 17-18, 2007
Tampa, Florida
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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