Laboratory Equipment Qualification

• Define the terms Validation and Laboratory Equipment Qualification
• List the four stages of Laboratory Equipment Qualification
• Describe each of the four stages of Laboratory Equipment Qualification: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Explain the terms Calibration and Preventative Maintenance

Learner Benefits:

• Solid Understanding of Validation and Qualification: Develop a clear grasp of key concepts, including validation and laboratory equipment qualification, ensuring you can articulate their significance in a regulated environment.

• Insight into Qualification Stages: Familiarize yourself with the four essential stages of laboratory equipment qualification—Design, Installation, Operational, and Performance Qualification—and the distinct requirements of each.

• Practical Knowledge of Documentation: Learn the necessity of rigorous documentation and how to prepare protocols, reports, and evidence to satisfy regulatory inspections and audits.

• Enhanced Awareness of Equipment Maintenance: Understand the role of preventative maintenance, calibration, and requalification in sustaining equipment performance and maintaining compliance with industry standards.

• Regulatory Compliance Mastery: Equip yourself with the knowledge needed to ensure that laboratory instruments adhere to FDA regulations, including the 21 CFR Part 11 guidelines for computer systems and software validation.

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