Grace McNally is a Senior Policy Advisor in CDER’s Office of Compliance, Office of Manufacturing and Product Quality. Previously, she served as a Compliance Officer handling domestic CGMP cases. She has participated in developing guidance for industry in the areas of process validation, combination products, contract manufacturing, participated in revisions of the CGMP regulation, as well as developing training for FDA and industry. Grace began her FDA career as a field investigator, first in Philadelphia District and then later in Denver District where she specialized in pharmaceutical and medical devices inspections. She graduated with a B.S. in physics from Boston College, Chestnut Hill, Massachusetts.