Live Q&A (A4)

W. Edwards Deming's 14 Points for Total Quality Management includes the following point: Improve constantly and forever every process for planning, production and service. A foundation of modern quality systems for all industries, this point speaks to the framework of the U.S. FDA's pharmaceutical process validation approach. 2021 marks the 10th anniversary of the U.S. FDA publishing the paradigm shifting Guidance for Industry: Process Validation: General Principles and Practices." This session will explore the lifecycle approach to process validation, including discussion of knowledge and data from development lots and commercial scale studies, along with continued process verification (CPV).

Representatives from FDA and regulated industry will present case studies and examples to illustrate how commercial manufacturers can ensure that the process remains in a state of control over the lifecycle of the product, which includes identifying opportunities and implementing changes to achieve continual improvement. Attend to listen to a discussion of where process validation is and can be - or should be - 10 years from now.