Process Validation

This course has been designed to help you understand the process validation concepts for medical devices and pharmaceutical products. This also covers the following:

• Determining which process must require validation
• Evaluate if the process is capable
• Monitors and controls for the process
• Statistical methods
• Software qualifications

Course Benefits

Participants will understand the validation process and master skills necessary to validate processes.

Topics Covered:

Module 1 – Validation Concepts, Terms, and Definitions

• Understand the basic concepts of process validation, including the need to validate
• Identify conditions when process validation is required
• State the QSR definition of process validation
• Compare and contrast process output verification with process validation
• Describe additional process requirements for validated processes
• Compare and contrast IQ, OQ, and PQ

Module 2 – The Requirements Framework

• Understand the requirements framework from FDA, ISO 13485, and OSHA
• State the requirements for process validation from the FDA QSR
• State the requirements for process validation from ISO 13485
• Explain the relationship between process validation and a) medical device reporting, b) corrections & removals, and c) risk management
• Identify the guidance documents published by FDA that relate to process validation
• Explain the role of sampling in determining the need for process validation
• Compare and contrast Lock Out – Tag Out with Machine Guarding

Module 3 – Process Validation Approaches

• Module 3.1 – Example
• Understand the typical approaches to process validation, the approaches that generated them, and a unified approach to implementation
• Compare and contrast the QSR and ISO 13485 requirements for process validation
• Define subsequent verification and its role in process validation
• Compare and contrast prospective, concurrent, and retrospective validation
• Compare and contrast installation, operational, and performance validation
• State the five interlocking parts of validation
• Explain the four process steps for each part

Module 4 – Installation Qualification

• Understand the elements typically included in Installation Qualification (IQ)
• Define Installation Qualification and describe its role
• State the QSR requirements for maintenance and describe how IQ contributes to conformity
• State the QSR requirements to post inherent limitations or allowable tolerances for equipment
• Identify the source for maintenance information
• State why you should identify all energy sources

Module 5 – Statistical Methods & Exercises

• Review three common statistical approaches required for process validation
• Review the process capability indices Cp and Cpk
• Review the fundamentals of the x-bar & R chart
• Review the concepts of designed experiments, both full and fractional factorial

Module 6 – Operational Qualification

• Understand the purpose and role of Operational Qualification in Process Validation
• Compare and contrast the FDA and GHTF definitions of Operational Qualification
• State the source of production specification in the QSR
• Describe challenge tests and their role in Operational Qualification
• Explain how challenge tests can be related to designed experiments

Module 7 – Performance Qualification

• Understand the purpose and role of Performance Qualification in Process Validation
• Compare and contrast the FDA and GHTF definitions of Performance Qualification
• Explain how performance monitoring can be related to statistical control methods
• Explain the role of action limits in performance monitoring

Module 8 – Software Qualification

• Understand the QSR and ISO 13485 requirements for software
• State the QSR requirements for production software
• State the ISO 13485 requirements for software used in production or service provision
• Describe the requirement for software validation in embedded systems in production equipment
• Part 11 requires validation of software used in electronic records or electronic signatures

Who Should Attend?

Individuals interested in learning how to conduct process validation, including engineers, managers, and project leaders.

Please Note: Price includes materials, certification.