Preclinical Development – Chemical
Lawrence Yu
Office Director, Office of new Drug Products, OPQ, CDER
FDA
Silver Spring, Maryland
Maya Lipert, PhD
Principal Scientist I
AbbVie
This presentation will provide an overview of the FDA quality initiatives, including Process Analytical Technology, Emerging Technology Program, Pharmaceutical Quality by Design, Integrated Quality Assessment, Concept of Operations for Facility Evaluation and Inspection, and introduce the FDA new quality initiative: Knowledge-aided Assessment and Structured Application (KASA).