Synopsis: In this podcast, Gerardo Gomez talks about the interactions between validation and technology transfer, considering the views and expectations of the regulators. As Gerardo explains, technology transfer is really a very sophisticated and complex project management activity and therefore needs to be carefully planned to avoid discrepancies or deviations from the regulations. Bio: Dr. Gerardo Gomez has more than 25 years of experience in the Pharmaceutical and Biotechnology industries.  He has held technical and leadership roles in the areas of validations, technical transfer, operations, and regulatory compliance in major biopharmaceutical companies.  As part of the PharmaLex leadership team, Gerardo is conducting both strategic and tactical (execution) projects, while playing key roles for PharmaLex clients – big and small – and for PharmaLex talent and business development initiatives.  Gerardo earned his Ph.D. in Pharmaceutical Sciences from the University of Michigan, after graduating magna cum laude from the Chemical Engineering department at The University of Puerto Rico.