Mourad F. Rahi
Senior Consultant Chemist
Preclintox Services, LLC
Dr. Mourad Rahi received a PhD in Chemistry from the University of Cincinnati, OH. His research centered on elucidation of metabolic pathways of Hydralazine, synthesis, and structure elucidation of metabolites. He also holds Mini-MBA from University of St. Thomas, MN.
Dr. Rahi is Honored Listee from Marquis Who’s Who! A consultant chemist for J&J MDR program. His career spans over 35 years in academia, management, and technical leadership in various CROs, medical devices and pharmaceutical companies. Dr. Rahi is a recognized expert and active speaker in international conferences on extractables and Leachables. He works closely with toxicologists to ensure valid analytical results for toxicological risk assessment. Dr. Rahi has extensive experience setting up analytical laboratories from ground-up, training chemists in the Art and Science of sample preparation, data acquisition, interpretation, and project design.
Dr. Rahi holds several patents related to innovations in medical devices and drug formulations, in addition to multiple publications.
DAY 2: MARCH 8th, 2024
SESSION: System suitability and incubation effects on extractables following exhaustive extraction
◆ The shortfalls of system suitability for determination of limit of detection as routinely performed for chemical characterization of solvent extracts of medical devices.
◆ The results and impact of a limited laboratory investigation on the effect of incubation on spiking selected standards commonly used for identification and quantification of extractables.
◆ Biocompatibility testing failure and identification of root cause.
◆ Recommendations to improve extraction and identification of reactive/toxic substances.
DAY 2: DECEMBER 1st, 2023
SESSION: Toxicological risk assessment, ISO certification, compliance, art and sciences of chemical characterization of nitrosamines. Are we doing the right thing?
◆ Ambiguity of guidelines for drugs vs medical devices for calculation of Analytical Evaluation Threshold (AET) for toxicological risk assessment.
◆ Effect of solvent selection and concentration of extracts on impurities profiling.
◆ Chromatographic and spectroscopic skills in mass spectra interpretation for identification of Nitrosamines in screening modes.
