Process Validation for Medical Devices: 2-day In-person Seminar 2013 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
Process Validation for Medical Devices: 2-day In-person Seminar 2013 is intended for:
- Production engineers
- Quality engineers
- Risk management specialists
- Design engineers
- Production supervisors
- Production managers
- Device QA/QC personnel
- Medical device manufacturers
