who should
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IntroductoryThis course is intended for professionals in the pharmaceutical industry who are charged with Pre-approval inspection readiness. Personnel working in Quality Control, Manufacturing, Regulatory Affairs and Quality Assurance along with their management and supervisory teams will benefit greatly from this training.
This training is part of a 10-course series required for the GMP Laboratory Control Professional Certification Program.
Click the image below to learn more about this Certification Program.
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 23 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 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 who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.