Is your production system capable of efficient, effective, and compliant device manufacturing?
It does if you have the right controls in place - including documented instructions, environmental control, adequate equipment properly installed and maintained, production software that you trust, properly controlled test equipment, and validated processes - and your system implements both FDA QSR and ISO 13485:2003.
Establishing Production Controls
Production controls start with design output and become device production specifications through the design transfer process. While the design stage ends, production controls continue for the life of the product. You will learn how to define and establish the controls needed for production including design transfer, quality plans, documented procedures, and instructions. You'll also learn techniques to identify, monitor, and control process parameters during production.
Production and Process Changes
FDA Investigators, using the Quality System Inspection Technique (QSIT), consider production and process changes as design changes and, as a result, expect appropriate documentation. You will learn how to create procedures to manage production and process changes, verify them, and determine when to apply process validation. You will also learn the aspects of document and record control that apply to changes.
Who Will Benefit:
Production Managers and Supervisors
Quality Managers and Supervisors
Manufacturing Engineering Managers and Supervisors
Quality Management System Auditors
Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.