Miguel Montalvo, President, Expert Validation Consulting, Inc.
Mr. Miguel Montalvo has over 34 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities. He is the owner and President of Expert Validation Consulting, Inc, a firm specialized on focused and practical consulting for the pharmaceutical, biologics, medical devices and OTC drug industries on cGMP compliance areas.
Before forming EVC, Mr. Montalvo held positions of increasing responsibility in the areas of Compliance Consulting, Validation, Technical Services and Quality Operations in companies such as AAC Consulting Group, Inc, Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. He has developed and implemented comprehensive and compliant GMP, Quality Systems and validation programs/systems for numerous companies and provided support/audits/assessments for many existing operations. His extensive expertise areas include development and implementation of quality functional procedures (QA/QC) and quality systems, internal and external cGMP audits including remediation efforts for companies under a consent decree, handling of non-conformances including investigations and deviations, all areas of validation, change control, CAPA, international GMP guidance and compliance, Calibrations, Risk Management and start-up of manufacturing facilities.
He holds a BS in Chemical Engineering from Rensselaer Polytechnic Institute and an MBA. He has been a frequent speaker/chairman/instructor at hundreds of compliance, validation and quality related conferences and courses around the world for such groups as PDA, PTi, CfPIE, IVT, Barnett International and the CTFA, his articles/papers have been published in the PDA Letter, American Pharmaceutical Review and the Journal of Validation Technology publications, he has authored chapters in recognized industry reference books and the PDA book on “Effective Implementation of Audit Programs”. He has been a member of the IVT Journal of Validation Technology Editorial Board and the PDA Annual Meeting Planning Committee.