Location

Productivity and Quality Institute - Alexandria

Objectives

• This highly participative equipment qualification training course is designed to ensure that you understand the current EU and FDA requirements for the design, execution, assessment and reporting of equipment qualification studies. Learn how the science and risk-based approach to validation can deliver business efficiency, increase reliability, enable robust processes and assure product quality. Doing so can add real value to your business while providing better protection to patients.This course will guide participants through the different stages of equipment qualification and present strategies for delivering new processes through a systematic approach. It includes guidance on how to plan and execute test cases to help identify operating ranges for general equipment qualification and process validation

Outcomes

1- Learning The key components expected for effective facility/utility/equipment qualification2- Learning Writing and documenting a user requirements specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)3- Distinguish between equipment qualification and validation • Identify regulatory standards and guidelines as they apply to equipment validation• Describe the purpose of each stage from equipment qualification to process validation 4- • Describe a procedural, systematic approach to support successful equipment lifecycle• Understand how to identify nominal ranges and operating limits for manufacturing equipment

Course Contents

• The Concept of Equipment qualification• Current Regulatory Expectations• Facility Design and Qualification of Equipment and Utilities• Benefits of Equipment Qualification• Equipment Qualification Process• Qualification Planning• Master Validation Plans• Qualification Need Assessment• Risk Classification• Direct Impact and Indirect Impact and No Impact• Impact Based Qualification Activities FAT (Factory Acceptance Testing)• SAT (Site Acceptance Testing)• Equipment Design Qualification (DQ)• DQ Review Documents• Installation Qualification (IQ)• Documents to Analyze During IQ Review• Pre-conditions for IQ Execution• Equipment Operational Qualification (OQ)• OQ and Commissioning• Pre-Conditions for OQ Execution:• Equipment Performance Qualification (PQ)• Pre-conditions for PQ execution:• Requalification• Change Control •