Course Description:
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
Seminar Fee Includes:
Who will Benefit:
- Warehouse
- Transportation
- Regulatory Affairs
- Quality Assurance
- Pharmaceutical Suppliers and Contractors
- 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
Course Outline:
| DAY ONE (8:30 AM – 4:30 PM) | DAY TWO (8:30 AM – 4:30 PM) | ||
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Registration Process: 8:30 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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Dr. Geoffrey Pan, PhD Partner/Senior Advisor, ChemPharm (S) Pte Ltd Dr. Geoffrey Pan has worked for more than twenty years in pharmaceutical industries, including development labs and statutory drug institutes in China, Singapore, New Zealand and Australia. He has experiences in formulation development, quality control, method development, validation, GxP training and auditing. He has worked in the fields of both western medicines and herbal medicines. He is currently a senior consultant in ChemPharm Asia, and participated GMP/GDP/GVP projects in mainland China, Hong Kong, Japan, and ASEAN countries. He helped strategise regulatory approval of a number of API/finish products in different countries. Dr. Geoffrey Pan is particularly familiar with regulatory requirements of ASEAN region. He has a wealth of knowledge in regulatory compliance, validations, project management, GMP/GLP/GDP, HACCP and regulatory affairs. |
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