Ajay Pazhayattil is an industrial pharmacist with pharmaceutical operational experience in sterile, solid oral, and API sectors of the industry. He has been with brand, generic, and CDMO organizations in leadership roles. Ajay is currently supporting pharmaceutical organizations in their process remediation and regulatory compliance efforts. He has successfully remediated process validation warning letter scenarios at large generic organizations. He is a contributing author, speaker, committee lead and influencer in the industry and has been part of developing and delivering regulatory acceptable unique process validation solutions. Ajay is one of the authors of ISPE Good Practice Guide: Practical Implementation of Lifecycle Approach to Process Validation, March 2019 and AAPS Solid Oral Dose Process Validation: Lifecycle Approach, Vol 1 and 2. He can be contacted through LinkedIn.