QMS Track:
Good Laboratory Practice & Project Management
Part I: GLP & GDP
Are you interested in how to effectively manage a research or testing laboratory to assure its competency and data integrity in meet international and/or regulatory requirements?
In this course, we will discuss internationally recognized guidance documents for good laboratory practice (GLP) and good documentation practice (GDP).We will also explore the organizational processes and quality management elements specified in ISO/IEC 17025 for assuring laboratory competence; including laboratory management, documentation/record control, reviews and audits, personnel training, test and calibration methods and validation, measurement traceability, data integrity and test reports.
Part II: Project management
Description: Based on the changing business society practice, by case learning, this course will enable students to master the knowledge of project concepts, project marketing and sales, project organization and leadership and project strategy and network.
Target: Through the study of this course, students can master the basic knowledge, principles of project management. The course also aims to foster the ability of students to solve the practical problems in project management with the international perspectives, master the project management system and the basic skills related to project management, as well as improvement of the level of professionalism and practical capability.
Good Laboratory Practices and Good Documentation Practices
Are you interested in how to effectively manage a research or testing laboratory to assure its competency and data integrity in meet international and/or regulatory requirements? In this course, we will discuss internationally recognized guidance documents for good laboratory practice (GLP) and good documentation practice (GDP). We will also explore the organizational processes and quality management elements for assuring laboratory competence，learn organizational management and quality management elements in laboratory management, and study typical cases . All participants will master the basic objectives and principles of GDP/GLP, understand the specific international knowledge and improve practical problem handing ability through case discussions.
Validation, Verification and Continual Improvements
The goals of international standard for quality management, ISO 9001, are 1) assurance that a process/product fulfills its intended purpose and meets customer satisfaction requirements; and 2) continual improvement of the organization and its quality management system (QMS). This course is for students interested in research and development of products/processes, or career development in manufacturing, quality assurance or corporate management. All participants will study the common methods used to achieve goals of international standard for quality management，including validation/verification，requirements and common tools for continual improvement of the organization and computer software validation. Upon completion of the course, students should have a good understanding of process/product validation and verification, as well as the common tools for continual improvement of the organization and its quality management system (QMS).
Design and Development Control
Product design development is very important to technology-oriented enterprises, so also in the medical device industry. The design and development control needs to be continually improved for the majority of Chinese enterprises, especially those lack of core technology, and whose main business relates to contract manufacturing. Shanghai United Imaging Healthcare Co., Ltd. (hereinafter referred to as United Imaging) has combined the medical device quality management system knowledge with the company’s product design and development practice and formed the course. This course is based on the ISO 13485:13485 Medical Devices-Quality Management Systems Requirements for Regulatory Purposes and also combined with United Imaging 7- years’ product development experiences. The key activities in the process of design and development are selected to present to our participants.
Audit Management and Supplier Control
The quality of medical equipment product is closely related to human life and health. China attaches great importance to the quality of medical device products and to the audit of medical devices. In the current years, under the impetus of government, medical device manufacturing enterprises have changed from the initial against attitude to quality audits to actively carry out the practice of quality audit and invite the third party for certification. The quality audit has played an important role for the Chinese medical device manufacturing enterprises to enter the international market. The course will explore quality audit and supplier management in the quality management system and Medical Devices Act，make participants are able to master audit process, principle, key contents, let participants have a deepen understanding of the importance of quality audit and supplier management and have a better understand the real operation of quality audit.
Special Requirements for Medical Devices
ISO 13485 is the most widely accepted international standard that specifies the quality management system (QMS) requirements for the medical device industry. Its third edition, issued in 2016, was adopted by China as the basis for regulatory requirement for Chinese medical device manufacturers. ISO 13485 is also a regulatory requirement in Japan and Canada, as well as the basis for European Union’s CE marking of medical devices. This course is for students curious about the regulatory requirements for medical devices industry, or those who are interested in working with medical device-related industries, as well as for those interested in career development and advancement in quality management systems. Upon completion of the course, students should have a good understanding of the CFDA’s requirements for medical devices industry, as well as the special requirements for medical devices as specified by ISO 13485:2016 and be able to apply them in medical device manufacturing.
Business Analysis Track:
Consumer Psychology
COURSE DESCRIPTION & OBJECTIVES (1) To understand established theories of how consumers form impressions, interpret information, and determine behavioral intentions. (2) To investigate the motivation and processes of why and how consumers make specific decisions and behave in certain ways—what motivates them, what captures their attention, and what retains their loyalty. (3) To better understand thoughts, information processing styles, and behavior of your own (as a consumer).
Negotiation
We negotiate almost every day. Yet, many of us know little about the strategy and psychology of effective negotiations. Why do we sometimes get our way while other times, we walk away feeling frustrated by our inability to achieve desired outcomes? Negotiation is the art and science of resolving conflicts and securing agreements between two or more interdependent parties. This course is designed to help you better understand the processes of negotiating and building consensus among stakeholders and improve your skills in negotiation, persuasion, deal-making, and dispute resolution. You will have the opportunity to develop your negotiating skills experientially and to gain insight into what works, what does not, and why.
Managing Technological Innovation
This course teaches hands-on management skills regarding innovation and is recommended for students planning to work in industry after they receive their degrees. It will cover the frameworks, models, and tools essential for the innovation process within a firm and apply them to case studies illustrating their importance. The course will progress in two parts. The strategic dimension will discuss how managers and executives can identify potential conflicts and complementarities between the firm’s technological assets and other resources both within and outside the organization. It will also provide useful tools for identifying which technologies are likely to succeed in markets, and which firms are best positioned to profit from this innovation. The management dimension of the course will discuss how firms develop innovative capabilities. It will also address the organization of the R&D function and the enabling of innovation through new products and processes. The teaching will combine case studies and lectures.
Business Strategy and Technological Innovation
This course is designed to provide a broad understanding of firm strategies that lead to technological innovation and firm growth. It introduces both academic research and business cases to help students apply this knowledge to practical cases. Students will get involved in searching relevant case studies and leading interactive group discussion throughout the class. This course will discuss important aspects of business strategy, including how firms recognize business opportunities, how they define and compete with potential rivals, and how they deal with a variety of stakeholders including upstream suppliers, downstream vendors, and regulatory agencies to sustain long-term growth. While the discuss strategies apply both to big firms and small startups, we will adopt a lens of high-tech startup founders to better understand how the strategies of entrepreneurs differ from big firms and how the strategies of different-sized firms can be harmonized. These discussions include how to deal with incumbent competitors, how to attract funds from investors, and how/when to contract with alliances so as to protect one’s own intellectual property and to avoid conflict of interests.
Principles of Business Statistics
A rigorous introduction to probability, mathematical statistics and statistical analysis, including such topics as data description and analysis, elementary probability theory, and simple and multiple regression analysis. Emphasis is placed on applications in economics and business problems.
Corporate Finance
This is a core compulsory course of Finance. Based on company's financial activities, this course mainly studies company's investment, financing and asset management activities. The focus of this course is on the company's financial activities, and the corresponding knowledge and skills are distributed in each chapter. The specific contents include what this course is about, analysis of the results of the company, the time value of capital, pricing of securities, capital budget, working capital management, capital cost and capital structure, dividend distribution etc.
Business Models
The study of business models investigates the interactions among all the stakeholders of the business, including enterprises, individual users, suppliers, and other participants. In different business models, the involved interactions present a variety of forms in terms of customer arrivals, flows of logistics and supply chains, information flows, and capital flows. This course will develop the analytical skills of students through case studies of business models, the exploration of new applications, new business model possibilities, highlighting new business models in traditional industries. Topics include electronic commerce, social networking platforms, new media, smart hardware, and online-to-offline models.
