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Process Validation for Medical Devices

  March 14, 2011  
The Center for Professional Innovation & Education, Berlin, Germany
May 16 - 18, 2011

Who Should Attend

This three-day course is targeted toward professionals directly involved in meeting the international and FDA's Quality System Validation requirements including 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) and/or ISO 13485, 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, ISO 13485 and the GHTF Validation guidance N99-10 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 one should validate.  Participants will learn how to comply with FDA and international regulations for validation protocols and determine the format and function of such protocols. Attendees will also learn 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 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
Organized by: Center for Professional Innovation & Education
Invited Speakers: info@cfpie.com
Deadline for Abstracts: n/a
Registration: http://www.cfpie.com/showitem.aspx?productid=089&source=hummolgen
E-mail: info@cfpie.com
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