who should
attend?
LEVEL
IntermediateThis course is intended for Lab Analysts, Supervisors and Managers in Pharmaceutical or Biological Laboratories who are responsible for generating, reviewing, evaluating or approving test results for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms in a regulated environment. This course will benefit individuals in:
– R&D
– Quality Control
– Quality Assurance
– Technical Operations
Regulatory affairs personnel responsible for the review of such data will also benefit from this course.
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.