Product quality is dependent on the operational efficacy of the manufacturing systems, their components, and their integrated functionality. Equipment qualification is a critical step to process validation, which is integral to meeting regulatory standards for any development and manufacturing organization. These processes, when properly conducted and documented, provide evidence that consistent parameters and acceptable tolerances are established for everyday equipment use in operations. 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. Additional topics include Quality by Design, the lifecycle of the process, regulatory standards and guidelines, multi and single-use technologies, unit operations, applicable Current Good Manufacturing Practices (cGMP), Commissioning, Qualification and Validation (CQV), and Installation, Operational, and Performance Qualifications (IQ, OQ, PQ)
• 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
• Describe a procedural, systematic approach to support successful equipment lifecycle
• Understand how to identify nominal ranges and operating limits for manufacturing equipment
This course is available online, and can be taken anytime, anywhere.