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Lifecycle Approach to API Process Validation

The goal of API process validation is to ensure the reliable production of high-quality active pharmaceutical ingredients from development through commercialization. The product lifecycle approach established in FDA's 2011 Process Validation Guidance requires different validation activities during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. The process validation needs for pre-qualification activities and ongoing process verification can be daunting, especially for small and medium-size pharmaceutical companies. In this webinar, experts on API process validation outline the key requirements for development of a phase appropriate manufacturing plan including regulatory requirements, data collection, specification development, critical process parameters, sampling plans, and analytical method validation. Key Learning Objectives: Understand the regulatory expectations at each clinical phase. Determine the key validation aspects of API manufacturing including critical process parameters. Identify analytical and stability needs as the API advances in the clinic. Moderator: Rita Peters Editorial Director Pharmaceutical Technology Speakers: Paul Wrezel, Ph.D. Director of Analytical Method Development Regis Technologies Bikash Chatterjee President and Chief Technology Officer Pharmatech Associates Inc. Paul L. Pluta, PhD Editor-in-Chief Journal of GXP Compliance and Journal of Validation Technology