Step-by-Step Process for Successful Sterility Failure Investigations

Danielle DeLucy

Pharmaceutical Quality & Microbiology Consultant

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for clients. In the years after, she held positions in quality management while increasing her responsibility. She has helped lead many Regulatory Health Inspections and was instrumental in coaching peers prior to inspections. Currently, Danielle assists companies faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems.