A Study on Management of Medical Product GMP & GDP and Related Internal Auditing Mechanism-- Case Study of TBMS Group Company

碩士 === 中原大學 === 企業管理研究所 === 105 === The objective of internal audit and control is to reasonably assure that the legitimate business management, compliance, asset security, financial reports and related information is true and complete, to improve operational efficiency and effectiveness, and to sli...

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Bibliographic Details
Main Authors: Yen-Chiang Lin, 林燕姜
Other Authors: Li-Lun Liu
Format: Others
Language:zh-TW
Published: 2017
Online Access:http://ndltd.ncl.edu.tw/handle/6x3ha5
Description
Summary:碩士 === 中原大學 === 企業管理研究所 === 105 === The objective of internal audit and control is to reasonably assure that the legitimate business management, compliance, asset security, financial reports and related information is true and complete, to improve operational efficiency and effectiveness, and to slightly improve the development of enterprise. It is expected that any unreasonable or inefficient subjects in current process can be identified. Any subjects that is inconsistent with rules and regulations, or subjects that cannot apply to current internal and external needs should be audited and reported timely in order to ensure the management system can be sustained and implemented effectively. With the company''s implementation of "Good Manufacturing Practice for Medical Devices"(GMP) and the consultation period of "Good Distribution Practice of Medical Equipment Specifications"(GDP), this study proactively participated in training, consulting and reviewing in order to obtain TFDA certification. As a result, the company will keep a valid medical device license(s) to ensure a sustained growth in medical devices sales.