Process Validation for Medical Devices

The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate 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.

By the end of this course, participants will learn how an effective process validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.

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 regulators

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.

Gordon Wehner is President of QualMed. QualMed works with both small, entrepreneurial firms and large, well-established medical-device and pharmaceutical organizations regarding audits, gap assessments, Good Distribution Practices, WEEE, RoHS and Supplier Management in Canada, the United States and Europe.

With nearly 25 years of experience in Quality Assurance, Regulatory and Clinical Affairs in the medical device and pharmaceutical industries; Mr. Wehner has worked with organizations both small and large – including four start-up organizations – to improve or establish quality management systems.

Mr. Wehner has an in-depth understanding of Canadian, US and international regulations for medical devices and pharmaceuticals; including ISO 13485:2003, ISO 14971:2007 and FDA Quality System Regulations. This experience includes the European Medical Device Directive – as well as Canadian, US and International GMPs. He has been directly involved in several design and development projects that include the application of Risk Management and Process Validation.

Mr. Wehner received his MSc in Biology from the University of Waterloo and his HBSc in Biology and MBA in Operations Strategy from Wilfrid Laurier University.