The FDA's Outlook for Quality in Device Manufacturing

This document provides detailed guidance on quality management and organization, device design, buildings, equipment, purchase and handling of components, and much more.Device manufacturing is regulated by FDA’s Center for Devices and Radiological Health. Unlike its sister Centers, CDRH not only publishes current Good Manufacturing Practices for the manufacture of devices (21 CFR 820), but also requires manufacturers to have a quality system for the design and production for all medical devices intended for commercial distribution in the United States. To assist the industry CDRH has published an excellent document titled Medical Device Quality Systems Manual.

Areas Covered in the seminar:
What a device manufacturer must do to meet the CDRH requirements for Quality Systems:

• Flexibility of the GMP and how to use it
• Quality Systems
• Design Controls
• Process Validation
• Equipment and Calibrations
• Device Master Records
• Factory Inspections

Who Will Benefit:
This program will provide a complete understanding of the GMP and Quality requirements for the design, manufacture, storage, distribution, and installation of Medical Devices including the requirements for complaint handling, and servicing. Employees who will benefit include:

• Manufacturing Managers and personnel
• Validation Specialists
• Quality Systems auditors
• Consultants to the Device Manufacturing industry
• Sub-Contractors to Device Manufacturers

Instructor Profile:
James R. Harris, PhD is a veteran of the pharmaceutical Industry and the president of James Harris Associates, an international consulting firm that specializes in the regulatory aspects of pharmaceutical, Biopharmaceutical, and device manufacturing. Dr. Harris played a vital role in establishing many of the regulations in existence today, with particular emphasis on validation of all types. He authored the original validation guideline for computerized systems used in drug manufacturing and has recently written a chapter on GMPs for the Pharmaceutical Manufacturing Handbook which will be published soon by John Wiley & Sons.