Computers and computerized systems are ubiquitous in pharmaceutical manufacturing. Validation of these systems is essential to assure public safety and compliance with appropriate regulatory issues regarding validation: GMP, GCP, 21CFR Part 11, etc. This course covers validation concepts for various classes of computerized systems and applications used in the pharmaceutical industry; importance of requirements engineering in validation; test protocols and design; organizational maturity considerations.

This course provides an overview of PAT applications in pharmaceutical operations.  At the conclusion of the course, students will understand the PAT life cycle, be able to identify PAT applications likely to yield positive benefit, understand issues of organizing and managing a PAT project and integrating the principles of Quality by Design into the effort (i.e. design control, facility and equipment control, production and process control, and material control).  Students will also understand the principles of integrating PAT application projects with the six-sigma approach to process improvement:  Define, Measure, Analyze, Improve and Control (DMAIC). Topics covered include:  PAT applications, risk analysis/risk management, project management issues (integrating PAT into process and product development, technology transfer to manufacturing, change management, etc.), and the PAT system project life cycle.  Examples of PAT impact on workflow, productivity, process variability and product quality will be discussed.

This course presents validation for medical device manufacturers in terms of its objectives, strategies, planning, protocols, and documentation.  Validation requirements include producing, collecting, analyzing, and managing data and documentation in support of medical device product design and product performance claims. These, as well as manufacturing processes and test methods, are presented within the context of current Quality System Regulations (QSR) as well as Risk Analysis. Qualification is addressed for equipment and operational systems, software and automated systems, and facilities for manufacturing medical devices. Validation in all life cycle phases is presented, both prior to commercial production and during the operating life of the plant, process, and product.  Case studies are included as specific examples. Through this course, students will understand how to implement validation studies for medical device manufacturers and to evaluate existing studies.