Using careful reviews of requirements from ISO 9001:2008, ISO 13485 and QSR along with case studies and in-class activities, learn the fundamentals and principles of process validation. Focus is on the planning, specifications, and requirements necessary to meet ISO and FDA requirements for process validation. FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics."

Process validation class discussions and team workshops also cover interpretation of process validation as described by the Global Harmonization Task Force and as required by FDA's Medical Device Quality System Regulation, ISO 9001, ISO 13485:2003.

Process Validation Objectives

• Understand the purpose, benefits and objectives of process validation
• Discuss ISO and FDA requirements for process validation as an integrated model
• Recognize planning and resource requirements
• Understand integration of computer systems controls into operations and facilities validations
• Describe the concepts of prospective, retrospective validation, and revalidation
• Understand performance qualification and equipment qualification, installation qualification, and operational qualification
• Differentiate between equipment, process, and product
• Understand validation techniques: organizing teams, process characterization, and process flowcharts
• Explain validation parameters: operating and process conditions, test methods, results analysis, acceptance criteria, limits testing, and computer control
• Follow validation protocols: guidelines, format, and presentation
• Establish records documentation requirements

Process Validation Topics

Introduction to process validation

• Key definitions and terms
• Principles and protocols
• Process validation
• Special process recognition
• Facilities validation
• Utilities and equipment
• Process capability design and qualification
• Validation program

Topics

Who Should Attend Process Validation Training?

Recommended for mid-level technical management, manufacturing engineering, facilities, production management, and quality assurance professionals involved in planning, executing, reporting, and maintaining manufacturing process validation.

CEUs: 2.5
Number of Days: 3