This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes, in establishing and implementing Process Performance, Product Quality, Monitoring, and Change Management systems in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management. It will help you link the science and risk-based process validation lifecycle approach to the Pharmaceutical Quality System.

It will provide you with practical application of quality risk management. Additional content will focus on technical approaches and

pharmaceutical quality management processes supported by quality risk management applied to process design, qualification of equipment,

utility and process performance

_{^{Who Should Attend}}

• Individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management
• Specific job functions include development, manufacturing, engineering, quality, and validation professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those that are new to the concept of process validation as a lifecycle

_^Outlines

• Fundamental of Process Validation
• Validation Life Cycle
• Validation Protocols
• The Future of Process Validation
• Statistical methods and tools for Process Validation