Process Validation for Medical Devices: 2-day In-person Seminar

The Process Validation for Medical Devices: 2-day In-person Seminar covers topics such as:

  • How to use process validation for ISO 14971:2007 risk reduction
  • Regulatory requirements from FDA QSR and ISO 13485:2003
  • How process validation supports the production and process control requirements of QSR
  • How to apply corrective action properly in solving problems
  • Applicable OSHA regulations, Hazard Analysis and Critical Control Point (HACCP) to ensure a robust system
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) techniques and their application in process control
  • How to use design of experiments (DOE) to define the input parameter space, an essential element of Operational Qualification
  • The relationship between "validated with a high degree of assurance" and process capability indices

The Process Validation for Medical Devices: 2-day In-person Seminar brings together attendees from Medical device manufacturers:

  • Production engineers
  • Quality engineers
  • Design engineers

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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