Description
One of the most common reasons noted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the regulatory intent of validation, the key for a robust process validation is the use of six sigma techniques and risk management. The rigor of a validation should be tied to the individual risk assessments of your products Critical Quality Attributes laid out in your design controls.
Using the GHTF Process Validation Guidance document as a backdrop, this seminar will provide a review of the fundamentals of validation, provide guidance on using a risk classification scheme to define the rigor of testing and provide a guidance on the use of Six Sigma tools to create and sustain a state of validated control.
