President - Miguel Montalvo
Mr. Montalvo is an experienced consultant for the pharmaceutical industry on compliance, quality systems and validation areas. Before forming EVC, he was a Vice-President for AAC Consulting Group where he directed the business unit for the Validation Compliance Group at AAC providing specialized compliance-focused consulting and management of validation projects for customers around the world.
Before joining AAC in 1999, Mr. Montalvo held positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations over a period of 20+ years in companies such as Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. He has managed the validation efforts for several facilities under start-ups and major renovations with processes including bulk API’s, solid-dosage, parenterals, topicals, liquids and medical devices for customers in the pharmaceutical and biotechnology segments. He has developed, reviewed, managed and audited quality and compliance functional procedures including those related with laboratory operations/QC, QA, Change Control management, Calibrations, procedural and documentation controls and internal audit programs for numerous companies. He is extremely familiar with cGMP and regulatory guidelines covering FDA, EU, PIC/S, WHO and ISO Standards in addition to ICH guidelines.
He holds an MBA and a BS in Chemical Engineering from Rensselaer Polytechnic Institute. His expertise includes areas such as Process and Cleaning Validation, Use of Statistics in different applications, Facility and Equipment Qualification with focus on Sterile Operations and Validation of Sterilization/Depyrogenation Processes. He has been a speaker at quality and validation related conferences around the world for such groups as PDA, PTi-International, CTFA, CfPIE, IIR, IVT and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications. He is co-author on the API facility chapter on the book "Good Design Practices for GMP Pharmaceutical Facilities" that was published in 2005. He is a member of the Journal Of Validation Technology editorial board. He is also a member of the PDA Annual Meeting Program Planning Committee for 2007 and 2008.
