GlobalCompliancePanel, United States
2012-05-02
Overview: 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 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 Session:- QMS Requirements for Process Validation
- FDA's QSR (21 CFR §820.75)
- ISO 13485:2003
- The Statistical Process Model
- 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
Learning objectives:- Understand the QSR requirements for process validation
- Explain the FDA’s approach as documented in Warning Letters
- Understand the ISO 13485 requirements for process validation
- State the statistical model that links process input and process output
- Link sampling verification to the process model
- Understand the role of process capability and describe the desired values of the indices
- Understand the role of designed experiments in determining the input parameter space
- Describe the role of challenge points in Operational Qualification
- Recognize the role of process validation in Risk Management
Who will benefit:- Quality Managers
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
- Design Engineers
- Process Owners
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Invited Speakers:
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Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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