Statistical Concepts of Process Validation - Webinar Recording/Transcript
Statistical Concepts of Process Validation
Many a medical devicemaker has incurred a warning letter due to slipshod process validation. No wonder. Process validation is an exacting task, subject to strict statistical procedures and hemmed in by 21 CFR §820.75 and ISO 13485:2016.
But compliance is only half the story. Failure in process validation leads to liability and lawsuits, while excellence in product validation leads ultimately to greater profits.
It’s time to brush up your process validation procedures and the perfect coach is Dan O’Leary, FDAnews’s go-to guy on technical training for devicemakers.
- QSR requirements for process validation
- The FDA’s approach as documented in warning letters
- ISO 13485:2016 requirements for process validation
- Linking process input and process output: The statistical model
- Linking sampling verification to the process model
- Role of process capability and desired values of indices
- Designed experiments: Role in determining input parameter space
- Challenge points: Role in Operational Qualification
- Risk management: Process validation’s role
Process validation is a process, one calling for patience and precision, training and retraining. Grab this opportunity for 90 minutes of training (or retraining) with the best in the business.