會員費用 : 港幣 1,500元
非會員費用 : 港幣 1,800元

查詢: 王小姐 - 電郵: training@gs1hk.org

有興趣人士請於2016年7月27日或之前於此網詀登記,我們將在活動前3個工作天發出確認電郵予成功預留座位之人士,並請以劃線支票支付報名費用,郵寄至「香港灣仔告士打道160號海外信託銀行大廈22樓 GS1 Hong Kong」。支票抬頭請註明「GS1 Hong Kong Ltd」,背面請填上貴公司的名稱及聯絡電話,並註明「Understanding the US FDA UDI Requirement and Implementation」。

Understanding the US FDA UDI Requirement and Implementation

Technology increasingly plays a vital role in improving patient safety and device surveillance. To identify the device more accurately and improve the data capture for better patient experience and medical device innovation, the US Food and Drug Administration (FDA) released a new rule of Unique Device Identification (UDI) in September 2013, which establishes that a common, worldwide system for product identification is required to apply onto all medical devices and device packages placed in the US market, unless excepted. 

  • unique device identifier number should be assigned by the device manufacturer to each version or model of a device
  • The unique device identifier should be both in human readable format and in AutoID format. By default, this information will be applied on the label of each device uniquely identified.

 

Why GS1?

GS1, a leading non-profit, global standards organisation, is accredited by the US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs). Global GS1 Standards meet the government’s criteria for UDIs and will help manufacturers to address requirements of the new FDA UDI regulation to support patient safety and supply chain security.

Date:              3 August 2016 (Wed)
Time:               2 to 5:30pm
Fee:                 Member           HKD 1500 
                        Non-member  HKD 1800
Instructor:       Mr. KK Suen, Chief Architect & Principal Consultant, GS1 Hong Kong
Language:       Cantonese

For enquiry, please contact training@gs1hk.org

To provide the industry stakeholders a structured framework and methodology in fulfilling this regulation, in this half day training, the instructor will cover:

  • Unique Device Identifier (UDI) Basic:
    - Structure of UDI (= DI + PI)
    - What is Device Identifier (DI)?
    - What is Production Identifier (PI)?
  • 3 Steps for Manufacturer to comply with FDA UDI requirements:
    - Numbering mechanism
    - Labeling requirement
    - Data upload to FDA database - Global Unique Device Identification Database (GUDID)
  • Exceptions

地點

灣仔告士打道160號海外信託銀行大廈22樓

前往方法

相關活動

13 May

09:30

This fundamental level course (Module 1) allows any user to apply Big Data Analytics skills in retail supply chain.  By attending the training, users will be equipped with the ability to apply data analytic tools to help the company discover insights and business intelligence to optimize business excellence.

08 Apr

09:30

透過兩天的培訓課程 -「理論 + 實踐 + 策略」,向從業員展示采用標準和新科技,以達到供應鏈的自動化和數碼化,並分享最佳範例,以迎接供應鏈4.0的走向。

查看所有活動

通過「讚好」GS1 Hong Kong 的 Facebook專頁獲取最新訊息。您將收到定期更新,並受邀請參加我們所有活動,讓你第一時間知道GS1 Hong Kong的動態。

icon_speaker_tab

置頂