Facilities of the Future

The "Periodic Review" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines how periodic review supports the continued maintenance of systems in a validated and qualified state. Participants explore the regulatory expectation that systems remain suitable for their intended purpose through lifecycle controls such as change control, maintenance, calibration, deviation management, and performance monitoring. The module also introduces a risk-based approach to determining periodic review frequency, including the use of review categories based on system…

The "Process Control and Automation" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines how GAMP® Quality Risk Management principles can be integrated with science- and risk-based C&Q for process control systems. Participants explore the relationship between manufacturing systems, process equipment, sensors, actuators, and Process Control Systems (PCS), as well as how product and process knowledge, Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs) inform automation and control requirements. The module also covers the…

The "Acceptance & Release" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines the final review and formal release of systems following the commissioning and qualification activities. Participants explore how testing results, discrepancies, engineering changes, and required quality system elements are reviewed to determine whether a system is suitable for manufacturing operations, the next stage of qualification, or use in PPQ or commercial production. The module also covers the transition of system ownership from the project team to operations…

The "Good Documentation Practice for C&Q" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines the documentation principles used to support clear, accurate, and reliable C&Q records. Participants explore how Good Documentation Practice supports data integrity through records that are attributable, legible, contemporaneously recorded, original or a true copy, and accurate. The module also compares commissioning and qualification documentation, including differences in approval, testing strategy, acceptance criteria, engineering judgment, Quality…

The "Implementation Strategy for New & Legacy Systems" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines how organizations can transition to a science- and risk-based C&Q approach for both new and existing systems. Participants explore the importance of organizational readiness, senior management support, quality systems, Good Engineering Practice (GEP), staff training, and a defined implementation plan when introducing a new C&Q strategy. The module also covers how the approach can be adapted for new projects, major changes, minor changes, and…