Dennis Saldana

FDA - Special Agent (Ret.)
Medical Device Expert / Pharmaceutical Manufacturing

Dennis Saldana is a former FDA Consumer Safety Officer for the Food & Drug Administration (FDA) and former Device Team Leader of the Los Angeles FDA regional office.

FDA Compliance. Dennis Saldana is an expert consultant for FDA safety and compliance with a particular focus on the Food, Drug & Cosmetic Act, GMPs, QSRs, GCP, GLP processes, MDSAP audit programs, and ISO-13485:2016 certifications. Mr. Saldana audited high technological manufacturing medical device companies such as in-vitro-diagnostics, catheters, computer-controlled ventilators, x-rays, lithotripters and liposorber systems, mechanical heart valves, intraocular lenses, and computer-controlled ventilators.

Client Services. Clients seek Mr. Saldana’s advice to either review or implement effective quality systems and internal assessment programs in FDA regulated industries—such as medical devices, pharmaceuticals, biological products, and others. Specifically, Mr. Saldana routinely plans, conducts, and manages division quality and regulatory compliance assessments pursuant to FDA-QSR, FDA-GMP, and ISO 9001/2 regulations. Additionally, Mr. Saldana offers clients significant experience in quality assurance work and project development (R&D, clinical, manufacturing phases) as well as the support to third-party manufacturing pharmaceutical facilities.

Training & Education. Mr. Saldana has taught QSR and GMP validation regulations and completed trainings as Quality Lead Auditor for International Quality Management Systems (ISO13485), FDA and the Changing Paradigm for Blood Regulations, ASQC Quality Audits for Improved Performance, Industrial Sterilization for Drugs and Devices, Medical Device Process Validation, AAMI Design Control Requirements and Industry Practice, and MDSAP/ISO13485 Certification, among others. Mr. Saldana earned a bachelor’s in science with a major in biology and a minor in chemistry from the Inter American University.