Welcome
Eunjoo Pacifici, PharmD, PhD
USC Mann School of Pharmacy and Pharmaceutical Sciences, Dept. of Reg. & Quality Sciences, Chair & Associate Professor | SC-CTSI, Director of Regulatory Knowledge Support | DK Kim lnternational Center for Regulatory Science, Associate Director
Good Clinical Practices and Preparing for an FDA Inspection
Nancy Pire-Smerkanich, DRSc, MS
USC Mann School of Pharmacy and Pharmaceutical Sciences, Dept. of Reg. & Quality Sciences, Assistant Professor | SC CTSI, Associate Director, Regulatory Knowledge and Support
Sponsor Audits: Data Handling and Reports
Nancy Pire-Smerkanich, DRSc, MS
Good Clinical Practice for Site Audits
Mike Sobczyk, MS
Gilead Sciences, Senior Director, Clinical Quality
Susan Bain, DRSc
USC Mann School of Pharmacy and Pharmaceutical Sciences, Dept. of Reg. & Quality Sciences, Assistant Professor
Good Distribution Practices (GDP2)
Lequina Myles, DRSc, MBA, RAC, PMP
Phenomenex | Senior Director, Quality Assurance and Regulatory Affairs
Nancy Pire-Smerkanich, DRSc, MS
Bioresearch Monitoring Program (BIMO) Good Clinical Practice Inspections
Susan Bain, DRSc
Wrap-up
Susan Bain, DRSc, Eunjoo Pacifici, PharmD, PhD