Production and Process Control: Building a Robust System 2017 is a workshop that covers topics such as:
- 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
Production and Process Control: Building a Robust System 2017 brings together:
- 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