HVAC Systems: Part 2 - Pharmaceutical Industry

About the Course

This eLearning course focuses on the qualification and lifecycle management of HVAC systems in GMP-regulated pharmaceutical environments. It covers system design considerations, DQ/IQ/OQ/PQ phases, risk-based approaches, change control, and ongoing performance monitoring. The course emphasizes regulatory expectations and best practices for maintaining a state of control throughout the HVAC system lifecycle. Content Qualification and Lifecycle Management of HVAC Systems Qualification concepts Phases of Commissioning & Qualification Qualification of HVAC Installation Qualification (IQ): Elements, Documentation and Compliance Operational Qualification (OQ) & Performance Qualification (PQ) Tests HEPA filter integrity test Non-Viable particulate counts test Viable particle counts test Air Velocity Test Air Changes Per Hour Area Recovery Test Airflow visualization test Lifecycle management Periodic Validation of HVAC Preventive Maintenance Procedures and Frequency External Vendor and HVAC Qualifications Regulatory actions Citations Auditing HVAC Systems and Cleanrooms Next steps for drug inspectors and regulators Summary and Conclusion: Life cycle management of of HVAC Systems Final Evaluation: 3 attempts to achieve 70% in the evaluation.