Process Validation for Medical Devices

• The Center for Professional Innovation & Education

The guideline on “General Principals of Process Validation” was issued in May, 1987, and subsequently, medical device companies have struggled with the principals of process validation. The FDA believes through careful design and validation of both the process and process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing.

Due to the complexity of today's medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness.

Learn how the FDA has identified a risk-based approach as one of the driving principles of the current Good Manufacturing Procedures (cGMP) initiative, and how the FDA believes the use of risk management principles will enhance the Agency's inspection and enforcement program.

Issues to be covered include:

*Assurance of product quality derived from a compliant validation program
*Learn best practices of protocol writing
*Understand the scope of current validation programs, and identify gaps
*Develop Remediation Plans
*Learn how to implement and deploy a Master Validation Plan
*Learn how poor validation procedures and practices can lead to regulatory actions from FDA