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Process Validation for Medical Device Development

Course Description

Enhance your understanding of process validation and how it is applied to the development of medical products. Learn how to assess an appropriate level of process scrutiny to provide a high level of confidence for process validation. Increase your knowledge of validation project management; basic approach to process validation; validation criteria for facilities and utilities; sterilization; controls, automated processes, and computer systems. Case studies illustrate how critical processes are validated in the development of medical devices.

Prerequisite: Eecs X445.2, Regulatory Requirements for Medical Devices or Eecs X445.26, Regulatory Requirements for Pharmaceuiticals; and Mgmt X442.6, Medical Product Quality Systems; or equivalent experience.

  • Details
  • $735
  • September 20, 2021 to November 28, 2021
  • Delivery Mode: Online
  • Reg#: 00156
  • ID/Units: BME X407  (3.00)
    ( Section 1 )
  • Quarter: FALL 2021

Instructor


Astor J. Suriano M.S. is a scientist and educator with over 15 years of academic and scientific research. He has more than a decade of Medical Device experience dealing with verification and validations for Johnson & Johnson Medical Devices. He served as a subject matter expert in new products in development, life cycle management, design controls, and test method validations for products in the R&D pipeline. His expertise is in applying six sigma methodologies, program and project management strategies for procurement, 510k filings, technical portfolios, continuous improvement, market launch and commercialization, and sustainability. He is actively engaged at local community colleges as a professor in higher education STEM programs.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

Required Textbook(s):

PROCESS VALIDATION FOR MEDICAL DEVICE DEVELOPMENT (A POCKET BOOK)
Book - ISBN: 1977834019
Emmet Tobin

PHARMACEUTICAL AND BIOMEDICAL PROJECT MANAGEMENT IN A CHANGING GLOBAL
Book - ISBN: 9780470293416
Scott D. Babler, John Wiley & Sons, Inc.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START09/20/2021Monday------Online (Access Begins)---
END11/28/2021Sunday------Online (Access Ends)---