Production and Process Control: Building a Robust System 2017

  • 31 Aug - 01 Sep, 2017
  • Westin Boston Waterfront, MA, United States

Description

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

Past Events

Important

Please, check "Production and Process Control: Building a Robust System" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Medical technology

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