Training Course
Syllabus:
Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)
Course Description:
In China´s latest public health scandal over the alleged illegal distribution of improperly stored vaccines that has reignited drug-safety concerns in China. According to state media, vaccines valued at almost $90 million have been distributed across the country. The health regulator says the vaccines were all produced by licensed manufacturers, but were stored and transported without proper refrigeration. The importance of GDP, in insuring the safety and quality of pharmaceutical products, is being more recognized by regulatory authorities. The new EU GDP Guideline in 2013, and the subsequent GDP Guideline by PIC/S in 2014, contains major changes and completely new contents. Learning Objective: Overview of GDP/GSP/GWP The requirements of GDP to facilities and personnel The relationship and integration of GDP with GMP Understanding the manufacturer´s requirements Regulatory requirements of GDP in different countries GDP in storage and distribution Equipment/facility validation Cold chain management Main changes of new EU GDP guidelines Understanding risk management in the supply chain Course Outline: DAY ONE (8:30 AM – 4:30 PM) Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM 8:30-10:15 Overview of GDP/GSP/GWP The requirements of GDP to facilities and personnel 10:15-10:25 Tea break 10:25-12:00 The relationship and integration of GDP with GMP Understanding the manufacturer’s requirements 12:00-1:00 Lunch 1:00-2:45 Regulatory requirements of GDP in different countries 2:45-2:55 Tea break 2:55-4:30 GDP in storage and distribution DAY TWO (8:30 AM – 4:30 PM) 8:30-10:15 Equipment/facility validation 10:15-10:25 Tea break 10:25-12:00 Cold chain management 12:00-1:00 Lunch 1:00-2:45 Main changes of new EU GDP guidelines 2:45-2:55 Tea break 2:55-4:30 Understanding risk management in the supply chain
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