4.0

credits

Average Course Rating

Understanding validation and applying a comprehensive validation philosophy are essential in today’s biotechnology industry. First and foremost, validation allows a company to operate in compliance with the regulations and guidance set forth by the FDA. Perhaps more importantly, it results in equipment assays and processes that are well-understood and robust, less prone to failure, and more cost-effective. This course will introduce the fundamentals of validation, validation master planning, resource management, types of validation and the associated documentation, departmental roles and interactions, and the differences between commissioning and validation. Students will have the opportunity to solve real-world problems, generate actual validation documents, and develop validation program elements that balance regulatory requirements, operational needs, and business expectations.