Review proposed regulationsDraft/review new or existing guidanceDraft/review new or existing compliance policyServe as consultant to CDER compliance officers when reviewing cases where FDA does not have a clear compliance policy

• Speaker "Aseptic Processing" CFDA meeting 11/2017• Speaker, case-study developer and manufacturing tract moderator at 09/2017 Taizhou and Jinan Pharmaceutical GMP workshops• Conducted pre-approval inspections that resulted in application withholds for Data Integrity and GMP issues• Instructor at 1-day data integrity inspection techniques training course for China FDA (CFDA) Drug Inspectors • Panel member and technical expert for FDA drug investigator training in meeting with CFDA Vice Minister and others, 2017• Panel member, technical expert, Drug GMP inspections, Taizhou, China industry round table 2016• Speaker, “Data Integrity”, Taizhou 2016 Pharmaceutical Summit• Appointed to 3-year term as a member of the Taizhou FDA Expert Drug Safety Committee• Instructor at FDA Systems Based Drug Inspections (subjects taught: Records and Reports, Investigations, Materials System, Packaging and Labeling System, Complaint Investigations and Laboratory System)

• Inspection of a large contract manufacturer of sterile pharmaceuticals resulted in an injunction• Inspection of 503B outsourcing facility resulted in a Warning Letter • Inspection of a foreign API re-packer resulted in a Warning Letter and “Detention Without Physical Examination” import alert for the firm. The firm initiated a recall of all lots packaged from 01/05/12 to 02/12/15.• Inspection of a sterile drug manufacturer resulted in a recall of an parenteral product• Instructor at FDA's Systems Based Drug Inspections (FDA's drug investigator training course I taught: investigations, FARs, records, liquids, semi-solids, suspensions, complaints, OOS, laboratory system and packaging and labeling system)• District expert in pharmaceutical inspections and responsible for conducting complex pharmaceutical establishments in the district and internationally.• Speaker – Xavier University Pharmalink 2015

Responsible for external messaging and trade press media relations

Managed communications to consumers, NGOs and trade press.