Process Validation for Medical Devices

This course is targeted to professionals directly involved in meeting the FDA's Quality System validation requirements such as those in regulatory affairs, quality assurance, process development or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who may have a basic understanding of the Quality System Regulation (QSR), including direct work experience.

This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation while offering information on how to implement an effective validation program. The course is also intended for Medical Device professionals who are responsible for performing process validation studies and ensuring compliance with regulatory requirements for validation documentation.

Typical attendees include:

Medical Device Validation Engineers

Medical Device Validation Specialists

Process Engineers

Quality Control Specialists

Facility Engineers/Managers

Medical Device QA/QC Managers

Medical Device Internal Auditors

Contamination Control personnel

Product/Process Development personnel

Research and Development personnel

Medical Device Manufacturing Specialists/Managers

Validation Managers/Specialists

Quality Control Analysts/Managers/Specialists

IT/IS Administrators/Directors

Software Engineers/Specialists

Compliance Supervisors

System Analysts/Administrators

Project Managers

Manufacturing Directors/Supervisors

Learning Objectives

The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why you should validate. Learn how to comply with FDA regulations for validation protocols and determine the format and function of such protocols. Addressed is how to maintain adequate validation documentation systems and perform equipment qualifications, process and software validations, and evaluate the need for re-validations.

Course Description

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