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.
Why you should attend:
* Did you know that poor or ineffective Process Validation was one of the top citations noted in recent FDA warning letters and 483’s?
* Do you know that poor or ineffective Process Validation also creates lower process yields and negatively impacts company profitability?
* Do you know how to create robust and complaint processes?
Areas Covered in the Session:
* Review the regulatory basis for process validation.
* Understand the difference between Validation and Verification.
* Review IQ, OQ, PQ
* Create a robust validation plan using six sigma techniques while maintaining compliance with QSR 820, ISO 13485, and GHTF.
* Creating risk classification scheme to help define the rigor of your validation.
* Using risk management at the Qualification stage to assist in revalidation and change control activities while in production.
* Using Risk Management to Maintain a state of control after initial validation is complete.
Who Will Benefit:
* Process Owners
* Quality Managers
* Quality Engineers
* Manufacturing Managers
* Manufacturing Supervisors
* Manufacturing Engineers
* Process Engineers
* Development Engineers
* Project Managers
For More Information: - http://bit.ly/9ivHPy