Douglas B. Hausner, PhD, is currently a Life Sciences SME/OSD Specialist at CRB. He brings more than a decade of pharmaceutical process experience to help lead complex large scale customer programs. He has been an ISPE member since 2011.
The creation of a new ICH guidance document, Q13,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and Drug Products.” Published July 2021.