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.