Polly Hanff

Background

About Polly Hanff

Expert in both domestic and international regulations for parenteral, sterile finished drug manufacturing including facility design, process simulation, airflow pattern testing, environmental control, and aseptic technique• Proficient regulatory inspection leader, fire tested through more than 25 agency inspections and more than 100 client regulatory audits. Leader of industry-first 3 agency (FDA, MHRA, TGA) joint inspection in 2011• Experienced in balancing competing priorities among compliance, drug shortage, remediation cost and timing within a complex product portfolio• Accomplished department and quality systems design through Consent Decree remediation baseline assessment, planning, writing, and rebuilding• Project leader with excellent risk management, communication, and presentation skills. Authored multiple risk assessments utilized in site strategic planning, product impact assessments, and facility remediation planning• Skillful talent manager, adept at hiring, coaching, promoting, and performance managing staff and people leaders