August 16th, 2013

Quality Management Systems

presented by Marianne Silva

This meeting is appropriate for those people in the medical products, clinical laboratory and food products industries who are currently developing or wish to improve the compliance or effectiveness of their company’s Quality Management System.

REGISTER HERE

The presentation on August 20th will provide:

  • An introduction to Quality Management Systems
  • Regulatory references for Quality Management System requirements
  • Discussions will include the application of Quality Management Systems as they relate to biologics, medical device, the food and supplement industries and the clinical laboratory environment.

Agenda

  • 5:30 pm – Registration and Networking
  • 5:45 pm – Dinner
  • 6:00 pm – Welcome and Introduction
  • 6:15 pm – Speaker
  • 7:45 pm – Break
  • 8:00 pm – Q&A Session
  • 8:15 pm – Raffle and VOC Survey
  • 8:30 pm – Adjournment

*Dinner is included with registration

Marianne’s presentation will focus on Quality Management Systems, references for Quality Management System requirements, and how to apply Quality Management systems to biologics, medical devices, clinical laboratories, and the food and supplement industries.

Marianne Silva is the Manager of Quality, Regulatory and Compliance for the USC Clinical Laboratories, Keck Hospital of USC and USC Kenneth Norris Jr. Cancer Hospitals. Marianne has a Masters Degree in Medical Technology, Immunohematology and Education in coordination with her SBB (Specialist in Blood Bank) training over 35 years ago. She was the Compliance Officer for a licensed blood center, the Compliance Officer for the Division of Transfusion Medicine at UCLA Medical Center, and the Instructor for medical technology students, teaching at California State University, Los Angeles for almost 10 years. Marianne is a Certified Quality Auditor and has over 35 years of experience in the Transfusion Medicine environment with an emphasis on regulations, accreditation, quality systems and compliance issues. Marianne worked for AABB Consulting Services Division, providing quality and regulatory solutions to clients across the United States and Canada.

Marianne has published multiple articles and a text on Quality, and has provided presentations at the local, state, national and international levels.