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EVENT DATE
Jul 2016
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Venue

Venue TBD Washington , District of Columbia
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Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)

Overview

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.

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. The GDP training provides an introduction to GDP for the pharmaceutical industry. This training course focuses on the differences between GDP and GMP, and their applications. GDP (GWP) regulations in Europe, US and other countries will be compared. This training addresses the rationale of maintaining a high level of GDP throughout the whole process of storage and distribution to protect the medicinal products distributed through the supply chain without any alternation. Some practical aspects of GDP, such as cold chain management, are also covered. This training is suitable for employees and professionals from storage, transportation, distribution, and related fields, who are involved in the various processes of drug logistics.

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

Who Will Benefit:

  • Employee in Warehouse
  • Employee in Transportation
  • Employee in Regulatory Affairs and Quality Assurance
  • Pharmaceutical Suppliers and Contractors
  • Employee in Logistics and Purchasing
  • In-house Legal Counsel and Contract Specialists
  • Business Acquisition Executives
  • Owners of New or Developing Import/Export Firms
  • International Trade Managers
  • Import Brokers
  • Sales Managers

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/pharma-supply-chain-and-good-distribution-practices-china-seminar-training-80381SEM-prdsm?channel=confevent

Notes:
Sponsorship Details:

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