Process Validation for Medical Devices - The Regulatory Approach

Why Should You Attend:

Process validation is one of the most common citations in medical device Warning Letters. This webinar explains the fundamental requirements for process validation with a focus on FDA QSR, but includes ISO 13485:2003. You will learn the regulatory requirements for process validation, the traditional components of process validation (IQ, OQ, and PQ), and the content of protocols and reports. The webinar examines FDA Warning Letters to help understand the requirements and explain what FDA Investigators look for. Because FDA Investigators follow the Quality System Inspection Technique (QSIT), the webinar explains the objectives and links them to the regulation and the Warning Letters.

Areas covered in this webinar:

• The process validation requirements in FDA QSR.
• The process validation requirements in ISO 13485:2003.
• Applying the traditional approach to IQ, OQ, & PQ.
• The QSIT approach and how FDA Investigators apply it.
• Warning Letters and how to learn from them.

Who Will Benefit:

The following personnel from medical device companies will benefit

• Design Engineers, especially engineers responsible for design transfer
• Manufacturing Engineers
• Quality Engineers
• Quality Auditors
• Regulatory Affairs
• Quality Systems Personnel
• R&D and Engineering Staff
• Risk Managers
• Production Supervisors

Instructor Profile:

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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