The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points for the Operational Qualification (OQ) phase. The guidance explains the concepts of process capability showing the relationship between the process statistical characterization and the engineering specification transferred from design. Statistical Process Control (SPC) is an important technique in the Performance Qualification (PQ) phase of validation.

Why you should attend:
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This is the essence of the statistical approach.

• Can you give the statistical rational for you verification sampling plans?
  
• Can you state the desired and actual process capability you need to achieve?
  
• Can you list the worst-case input parameter combination for your process?
  
• Do you know how to determine challenge points for your process?
  
• Have you set action limits for your process inputs?

Areas Covered In the Seminar:

• QMS Requirements for Process Validation
  • FDA’s QSR (21 CFR §820.75)
  • ISO 13485:2003
• The Statistical Process Model
  • Relating input to output
• The Process Output
  • Sampling Inspection
  • Process Capability
• The Process Input Parameters
  • Design of Experiments
  • The Challenge Points
• Risk Management
  • Production Information
  • Validated Processes as High Risk

Who will benefit: People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Engineers
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners