- Learn how to integrate audit readiness into facility design and startup activities
- Understand critical quality system elements that support regulatory success
- Explore leadership strategies for cross-functional alignment and compliance culture
- Review case studies from greenfield and clinical facility launches
LeeAnn Chrisco
Director of Quality Assurance
INCOG BioPharma Services, Inc.
LeeAnn Chrisco is an accomplished Quality Assurance executive with over 20 years of leadership in GMP manufacturing and compliance. As Director of Quality Assurance at INCOG Biopharma Services, she provides strategic QA oversight across manufacturing, packaging, and quality control, ensuring global regulatory compliance. LeeAnn has led audit readiness, regulatory agency interactions, and facility startups for clinical and commercial operations. Her expertise spans technical transfer, aseptic processing, and quality systems innovation. A contributing author to ISPE and BioPhorum publications, LeeAnn brings deep industry insight and a passion for building high-performing quality cultures in fast-paced, regulated environments.
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INCOG BioPharma Services, Inc.
INCOG has been designed and built from decades of experience with a clear purpose: to deliver better CDMO services in the injectable drug product space.
With our dedicated team, best-in-class processes, and state-of-the-art equipment, we deliver meaningful results and stand-out customer experiences. We are here to strive for the best—for our team and for our customers. We are in it with you from the moment we start work on your project. We go above and beyond to understand your requirements, meet your needs, and foster a truly collaborative partnership.
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Founded in June 2020, INCOG BioPharma Services offers development and manufacturing services to both early phase and late phase biopharmaceutical companies. We are located on the northeast corner of Indianapolis in Fishers, IN.
