Course Description:
Quality Risk Management is now at the cutting edge of the life sciences industry internationally. ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated in GMP by the MHRA, PIC/S and the EMEA.
Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS). Pharmaceutical professionals should be able to use risk management techniques and tools based on ICHQ9 to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System.
This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place.
Note: This course will be taught by a native Chinese instructor in Chinese language.
注：本课程将通过中国语文中国本土教练授课。
Learning Objective:
- General principles and approach to risk management
- Regulatory requirements for application of risk principles
- Key steps and activities for a risk management program
- How compliance and risk management are strategically used
- Principles and requirements of ICH Q9
- How to classify cGMP non-conformances according to risk priority
- Hazard Analysis and Critical Control Point (HACCP) in production and process control
- How to apply risk management principles in process design
- How to use HACCP tables to maintain process control of production lines
- The different tools applicable to risk management
- Failure Mode and Effect Analysis (FMEA) for an example pharmaceutical product
- How to apply risk management to validation
Who Will Benefit:
The course is designed to service a wide range of participants from various disciplines within the pharmaceutical and medical device industry. Typically participants will be managers or supervisors who have experiences in a GMP related environment and need QRM to perform in their current position.
- Quality
- Production
- R&D
- Validation
- Engineering
- Risk
- Operations
- Manufacturing
- Project
Seminar Fee Includes:
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 – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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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. |
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Local Attractions
Yu Garden
Yu Garden the forbidden city or Yuyuan Garden, the Garden of Happiness, is an extensive Chinese garden located beside the City God Temple in the northeast of the Old City of Shanghai. It abuts the Yuyuan Tourist Mart and is accessible from the Shanghai Metro's Line 10 Yuyuan Garden Station. A centerpiece is the Currow ancient stone, a porous 3.3-m, 5-ton boulder. Rumours about its origin include the story that it was meant for the imperial palace in Beijing, but was salvaged after the boat sank off Shanghai. Yu Garden was first built in 1559 during the Ming Dynasty by Pan Yunduan as a comfort for his father, the minister Pan En, in his old age.
Nanjing Road
Nanjing Road is the main shopping street of Shanghai, and is one of the world's busiest shopping streets. The street is named after the city of Nanjing, capital of Jiangsu province neighbouring Shanghai. Today's Nanjing Road comprises two sections, Nanjing Road East and Nanjing Road West. In some contexts, "Nanjing Road" refers only to what was pre-1945 Nanjing Road, today's Nanjing Road East, which is largely pedestrianised. Before the adoption of the pinyin romanisation in the 1950s, its name was rendered as Nanking Road in English. The history of Nanjing Road can be traced back to the year 1845. At that time it was called “Park Lane”, which stretched from the Bund to He’nan Road.
People's Square
People's Square is a large public square in the Huangpu District of Shanghai. It is south of Nanjing Road (West) and north of Huaihai Road (East). People's Square is the site of Shanghai's municipal government headquarters building and is used as the standard reference point for measurement of distance in the Shanghai municipality. Prior to 1949 and the establishment of the People's Republic of China, what is now People's Square was a course for horse racing owned by the Shanghai Race Club. After gambling and horse racing were banned by the new Communist government, a part of the race course became People's Square, which included a large avenue and spectator stands for use during parades.
Oriental Pearl Tower
The Oriental Pearl Radio & TV Tower is a TV tower in Shanghai, China. Its location at the tip of Lujiazui in the Pudong district by the side of Huangpu River, opposite The Bund, makes it a distinct landmark in the area. Its principal designers were Jiang Huan Chen, Lin Benlin, and Zhang Xiulin. Construction began in 1991, and the tower was completed in 1994. At 468 m (1,535 feet) high, it was the tallest structure in China from 1994–2007, when it was surpassed by the Shanghai World Financial Center. It is classified as a AAAAA scenic area by the China National Tourism Administration. The tower is brightly lit in different LED sequences at night.
Jade Buddha Temple
The Jade Buddha Temple is a Buddhist temple in Shanghai. As with many modern Chinese Buddhist temples, the current temple draws from both the Pure Land and Chan traditions of Mahayana Buddhism. It was founded in 1882 with two jade Buddha statues imported to Shanghai from Burma by sea. These were a sitting Buddha (1.95 meters tall, 3 tonnes), and a smaller reclining Buddha representing the Buddha's death. The temple now also contains a much larger reclining Buddha made of marble, donated from Singapore, and visitors may mistake this larger sculpture for the original, smaller piece.
