Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This interactive course provides more than the usual project basics. It develops the concept of project lifecycle from initiation through delivery of business benefits, along with tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of "good practice" project management. Trends in regulatory compliance, environmental, health and safety legislations, project delivery methodologies, and product speed-to-market expectations all impact how pharmaceutical facility projects are managed. Each course module introduces key project management concepts and tools as well as methodologies that specifically support successful project delivery.
The course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.