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
Who should Attend
Attendees from Medical device manufacturers:
Production engineers
Quality engineers
Design engineers
Past Events
Process Validation for Medical Devices: 2-day In-person Seminar 2016 - 28-29 Mar 2016, San Francisco, California, United States (55236)
Process Validation for Medical Devices: 2-day In-person Seminar 2013 - 21-22 Aug 2013, Courtyard Boston Cambridge, Massachusetts, United States (39821)
Important
Please, check "Process Validation for Medical Devices: 2-day In-person Seminar" official website for possible changes, before making any traveling arrangements
