Program Overview
This intensive program provides laboratory professionals with deep-domain knowledge and hands-on expertise in IQ, OQ, and PQ processes. The course combines conceptual understanding, real-world case studies, and interactive exercises. Participants will learn to design, implement, and troubleshoot qualification protocols to ensure equipment accuracy, reliability, and compliance with regulatory standards such as FDA, GMP, and ISO 17025. With an emphasis on situational awareness and problem-solving, this program equips participants to resolve real-world challenges and drive operational excellence in laboratory environments.
Features
- Understand the purpose, process, and importance of IQ, OQ, and PQ in laboratory operations.
- Develop risk-based strategies to design and implement qualification protocols.
- Analyze real-world case studies and troubleshoot IQ, OQ, and PQ challenges effectively.
- Ensure regulatory compliance while optimizing equipment performance and reliability.
Target audiences
- Laboratory Managers
- Quality Assurance Professionals
- Validation Engineers
- Technical Staff
- Compliance Specialists
Curriculum
- 3 Sections
- 21 Lessons
- 3 Days
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- What is Installation Qualification (IQ)?7
- 1.1Purpose, scope, and critical importance in laboratory operations.
- 1.2Regulatory landscape: FDA, GMP, ISO 17025 requirements for installation qualification.
- 1.3Key components of IQ: Site preparation, documentation, and verification of installation parameters.
- 1.4User Requirements Specification (URS), Validation Master Plan (VMP), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
- 1.5Common challenges in IQ: Handling non-conformities during equipment installation; Risk management in installations involving complex systems.
- 1.6Case Study: A failed IQ implementation in a pharmaceutical lab and lessons learned.
- 1.7Interactive Exercise: Design an IQ protocol for a newly installed chromatography system.
- What is Operational Qualification (OQ)?7
- 2.1Purpose and scope of OQ: Verifying equipment operates as intended under predefined conditions.
- 2.2Defining and testing critical operating parameters.
- 2.3Documentation and acceptance criteria: What auditors expect.
- 2.4Operational Parameters, Calibration, Acceptance Range, Test Scripts, and Design of Experiments (DOE).
- 2.5Troubleshooting OQ failures: What to do when equipment fails operational testing; Revisiting acceptance criteria: Setting realistic thresholds.
- 2.6Case Study: OQ challenges in validating an automated liquid handler.
- 2.7Simulation: Create an OQ plan for a temperature-controlled incubator, including defining tests and acceptance ranges.
- What is Performance Qualification (PQ)?7
- 3.1Verifying that equipment consistently performs under actual operating conditions.
- 3.2Integrating PQ with process validation.
- 3.3Aligning PQ protocols with regulatory compliance and business goals.
- 3.4Process Validation, Routine Monitoring, Performance Metrics, and Worst-Case Testing.
- 3.5Risk management in PQ: Identifying worst-case scenarios; Addressing variances and deviations in real-world use cases.
- 3.6Case Study: Handling a PQ failure in an HPLC system and redesigning the protocol.
- 3.7Group Simulation: Design and execute a PQ protocol for a spectrophotometer, including a worst-case testing scenario.
Instructor
