Dr. Ajay Babu Pazhayattil
With a background in industrial pharmacy and executive management, Dr. Ajay Pazhayattil has a proven track record of driving innovation in brand, generic/biosimilar, and CDMO bio-pharmaceutical organizations. Ajay is a known Validation SME applying manufacturing science principles and product/process data to develop regulatory-compliant approaches for US FDA-regulated bio-pharmaceutical operations. He has been extensively involved in new facility commissioning and qualifications, new product launches, and legacy product/process remediations, primarily focused on the US market. Ajay’s passion for the subject has also led him to be actively involved in various industry organizations as a thought leader, contributing significantly to the practical applicability of regulations. He is an author of the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation. Ajay regularly publishes journal articles and textbooks with ISPE and for other key industry organizations such as PDA, AAPS, and RAPS.