Who Should Attend

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

View Course Agenda

“Wow!  Finally a course created for and focusing on the needs of the medical device industry.  The course director brings a ton of experience and worldly knowledge and it showed.  I particularly liked the inclusion of focus on validation master plans…not simply focusing only on IQ/OQ/PQ’s.  Well done.  The hotel is very nice as a conference location.”
Robert P., Manufacturing Engineer, Abbott

“There was a lot of material covered.  I was impressed with the way the instructor set the course up.  IQ OQ PQ was first, followed by process validations, DOE’s, FMEA’s, software validations and why all these are required.  The instructor made the class feel comfortable from day one and encouraged questions.  I definitely have more confidence about the work I am doing.”
Matt C., Biomaterials Quality Engineer, Globus Medical

“The Course Director answered the questions of the group directly and did not make the answer more confusing than the question.  This implied a willingness to “take a stand” on a validation issue.”
Stephen C., Sr. Quality Engineer, Synthes

“Excellent course!  I now have a much better understanding of what needs to be done, how much and how to do it.  Thank you.”
Kathy D., QC Engineer, Globus Medical