Grace McNally is Branch Chief (acting), Regulatory Policy and Collaboration Branch, in CDER’s Office of Compliance, Office of Manufacturing and Product Quality. Previously, she served as Senior Policy Advisor in the Guidance and Policy Team and as a Compliance Officer handling domestic CGMP cases. She is active on several Guidance working groups dealing with process validation, combination products and revisions of the CGMPs, as well as developing training for FDA and industry. Grace began her FDA career with ORA (Office of Regulatory Affairs) working in the Philadelphia Distric t, and Denver District respectively where she specialized in pharmaceutical and medical devices inspections. She graduated from Boston College, Chestnut Hill, MA.