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FMMC Breakfast Briefing: Effective Management of Purchasing Controls
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FMMC Breakfast Briefing: Effective Management of Purchasing Controls

FMMC Breakfast Briefing: "Effective Management of Purchasing Controls to Meet Medical Device Requirements" Marie B. Teixeira President and Principal Consultant QA/RA Compliance Connection, Inc.

3/26/2015
When: 03/26/2015
8:00 AM
Where: Hilton Carillon Park
950 Lake Carillon Drive
Van Gogh Room
St. Petersburg, Florida  33716
United States
Presenter: Marie B. Teixeira, QA/RA Compliance Connection, Inc.
Contact: FMMC
(850) 270-3158


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"Effective Management of Purchasing Controls to Meet Medical Device Requirements"

Marie B. Teixeira

President and Principal Consultant 
QA/RA Compliance Connection, Inc.
 
Among other topics, this informative session on purchasing controls will cover:
o Determining supplier risk categories
o Establishing acceptance criteria for suppliers
o Evaluating suppliers against acceptance criteria based on assigned risk 
o Establishing supplier agreements
o Establishing an approved supplier list and associated supplier files
o Continued monitoring of suppliers for acceptability
o Continued monitoring of data for feedback into purchasing controls

 

About our Speaker:

 

Marie Teixeira is the President and principal consultant for QA/RA Compliance Connection, Inc. in Odessa, Florida. For over fifteen years Marie has been providing expert consulting services and management for her clients in all aspects of global quality system compliance and regulatory affairs.

Before beginning this venture, she was Director of Quality Assurance and Regulatory Affairs at Bioderm, Inc., a start-up medical device company in the Tampa Bay Florida area where she designed, directed and implemented the policies and procedures that established this company's compliance with global regulatory requirements.

Ms. Teixeira was also Quality Systems Manager for Regulatory Affairs at Smith & Nephew's Wound Management Division in Largo, Florida. In addition to directing the planning, development and implementation of Smith & Nephew's ISO 13485, FDA GMP, and MDD 93/42/EEC regulatory efforts, she implemented and directed the company's internal audit and management review system. It was her direction and guidance that allowed Smith & Nephew's Wound Management Division to achieve ISO certification in less than a year, as well as their MDD certification one year later.

Ms. Teixeira began her career as a Quality Engineer for Raytheon, GTE Government Systems and Sparton Electronics. During her tenure at these companies she was responsible for establishing and implementing quality assurance programs and procedures, leading supplier and customer audits, developing and performing quality system and auditor training, initiating and managing corrective actions, and developing and implementing supplier certification programs. During her tenure at Sparton, she managed the company through its initial ISO certification and subsequent surveillance audits.

Marie Teixeira holds a BS in Industrial Engineering and Operations Research from the University of Massachusetts at Amherst. She is a member of the American Society for Quality. Ms. Teixeira is an ASQ Certified Quality Manager and Quality Engineer and an RABQSA Principle Auditor. Ms. Teixeira was also an active member of an international task force CEN/TC257/SC-DETG10 - whose objective was to standardize medical device nomenclature. Ms. Teixeira recently authored her second edition of the book titled "Design Controls for the Medical Device Industry". Ms. Teixeira has also published numerous quality system related CD-ROM training modules and related informational handbooks and has conducted numerous quality system training seminars.

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