Introduction to Process Validation

Course Description: This preparatory course provides a hands-on review of manufacturing process validation for medical devices. It lays out the key principles of process validation, including regulatory requirements. The basic statistical considerations for process validation are clearly illustrated in an example. This course covers the following topics: What is process validation? What is verification? When should process validation take place in lieu of verification? Regulatory expectations The concept of “variation” The concept of “process capability” Process inputs General requirements for process validation The three phases of process validation European regulatory requirements for process validation US regulatory requirements for process validation Planning and outputs related to process validation Contribution of risk management to process validation At the end of this course there is a brief slideshow of warning letters from the US FDA addressing findings related to process validation. Learn more at: http://ift.tt/2A0zQTE