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

Seminar Summary:

This course puts these into a logical perspective so that the participant can identify the correct GDP requirements unique to their company's operations, including those for material management, manufacturing control and packaging control. (see full course description)

print this agenda