Applying GDP to Biologics
Mary Foster, Pharm.D, USP Chair – PSD Expert Committee 2015-2020, presented a workshop on the applications of Good Distribution Practices to biologic shipping at the last Biologistics Summit. Her workshop session on the applications of GDP to biologics was hard-hitting and informative. IQPC has transcribed the session, including attendee dialogue, into this 50-page eBook which includes:
In the e-book she discusses:
• Commercial vs. Clinical
• Quality Management
• Environmental Conditions Management
• Procurement
• Risk Assessment
• FDA 43
• Importation & Exportation
Source: IQPC
