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Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)

 
  June 03, 2016  
     
 
ComplianceOnline, Shanghai, China
2016-07-04


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

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

Note:
Use coupon code NB5SQH8N and get 10% off on registration.
 
 
Organized by: ComplianceOnline
Invited Speakers: Chuan Yao, 
Principal Consultant

Chuan Yao has over 25 years of experience in the pharmaceutical and medical device industry and has worked in the industry in China, New Zealand, Australia, Singapore and other ASEAN countries. Chuan has held senior positions in the areas of Quality Assurance, Regulatory Compliance and Regulatory Affairs and has been responsible for maintenance of regulatory compliance of active ingredient manufacturer's drug master files (DMF) and European certificates of suitability (CEPs). Chuan also has extensive analytical testing and quality control experience, production engineering experience involving trouble shooting, process optimization and long term process / product development activities. He is currently a principal consultant in ChemPharm Asia, and leading consultant team to participate GMP/GDP/GVP projects in mainland China, Hong Kong, Taiwan, Japan, and ASEAN countries. Chuan has a wealth of knowledge in regulatory compliance, validations, project management, GMP/GLP/GDP/GVP and regulatory affairs, he has designed and conducted series of GxP training courses to train thousands of industry professional. Chuan is fluent in English and Chinese.

 
Deadline for Abstracts: 2016-07-03
 
Registration:
For Registration:
http://www.complianceonline.com/pharma-supply-chain-and-good-distribution-practices-china-seminar-training-80381SEM-prdsm?channel=hum-molgen
 
referral@complianceonline.com
Phone No : +1-888-717-2436 
E-mail: referral@complianceonline.com
 
   
 
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