Production and Process Control: Building a Robust System 2017

Topics

• The approach regulators use to check implementation including QSIT and MDSAP
• Regulatory environment for device manufacturers including FDA QSR, ISO 13485:2003 and ISO 13485:2016
• How to manage inspection, measuring and test equipment, IMTE
• The requirements for installation and maintenance of production equipment
• Product verification requirements and records
• The requirements for production and test software validation
• How to handle nonconforming product and keep the required records
• When to validate a process and the most common approach (IQ, OQ, and PQ)
• Concepts of production process control
• The role of quality plans, process flowcharts and process FMECAs
• Data types (attributes and variables)
• The underlying statistical concepts including statistical distributions and decision making
• Methods to calculate and use process capability
• The SPC methods available for the data types

Who should Attend

• Quality Managers and Supervisors
• Production Managers and Supervisors
• Manufacturing Engineering Managers and Supervisors
• Quality Engineers
• Quality Management System Auditors
• Manufacturing Engineers
• Regulatory Affairs and Compliance Staff
• Risk Management Specialists