Collaborators
Alfred Del Grosso, Ph.D.
Former FDA laboratory manager and reviewer. Extensive experience at FDA CBER in review of analytical procedures and validations for bacterial and viral vaccines, blood products and allergenic products. Managed FDA analytical chemistry laboratory that utilized spectroscopic, chromatographic, and wet chemical methodologies in an ISO 17025 compliant laboratory.
Strong background in development, validation, and implementation of HPLC, GC and Mass Spectrometric methods.
In-depth knowledge about FDA expectations for analytical procedures, validations, verification of Compendial methods, methods transfer and qualification. Use of Quality by Design (QbD) to evaluate
method robustness and overall method adequacy.
Expertise in Laboratory Quality Management to cGMP standards and ISO 17025 Establishment of drug substance and drug product specifications based on identification of critical Quality attributes and measurement capabilities.