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Course Instructor

Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

DeLucy_Danielle

Danielle DeLucy, M.S., is the 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 23 years, serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices, and providing 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 their clients. In the years after, she has held positions 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 that are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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