Statistical Concepts of Process Validation

The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".

The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts. 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. The presentation concludes by showing the strong relationship between validated processes and Risk Management. ISO 14971:2007 requires that production (and post-production) information go back to Risk Assessment to help complete the life cycle. Validated processes, where the manufacturer cannot fully verify the output, present a risk of product “escape”. Statistical information of each lot from a validated process should be part of the Risk Management File.

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. This webinar presents the statistical approach that will help you validate your processes. Your team should attend this webinar if you cannot easily answer these questions.
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

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

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