Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC, providing pharmaceutical and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance. Danielle has been in the industry for over 15 years, serving in numerous quality management roles, such as the Director of Product Quality, where she oversaw sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle began her career as a Quality Control Pharmaceutical Microbiologist, performing various tests for laboratory clients.  She’s continued in the quality management arena while increasing her responsibility.  She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection.

Currently, Danielle assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.