速報APP / 教育 / FDA Inspection Preparation

FDA Inspection Preparation

價格:免費

更新日期:2019-05-12

檔案大小:3.1M

目前版本:1.0

版本需求:Android 4.0 以上版本

官方網站:mailto:Appzinnovative@gmail.com

FDA Inspection Preparation(圖1)-速報App

This application will helpful for understanding how & what kind of Inspections are conducted in pharmaceutical Industry.

Objectives:

1) You will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements

2) You will get a deeper understanding what FDA and other global regulatory inspectors expects from pharmaceutical companies in regard to Data Integrity

FDA Inspection Preparation(圖2)-速報App

3) You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System

4) You will learn how to prepare your company for an successful inspection in regard to Data Integrity

5) You will understand how to establish an effective Data Governance system

6) You will learn how to investigate Data Integrity issues in your company

FDA Inspection Preparation(圖3)-速報App

You Will Learn:

1) Basic & Advance Concepts of Data Integrity

2) Computer System Validation Tips,

3) Mock Inspection Question & Answer

FDA Inspection Preparation(圖4)-速報App

4) Checklist for Inspection

5) Industry Best Practices to Maintain Data Integrity

6) Useful Reference & Resources

7) Current regulatory thinking on Data Integrity

FDA Inspection Preparation(圖5)-速報App

8) And much, much more…

Who Will Benefit:

1) Pharmaceutical/ Medical device / Healthcare/Life science Industry personnel

2) Validation/ IT Service Providers

FDA Inspection Preparation(圖6)-速報App

3) Developers of software for use in Life Sciences industry

4) Regulatory Affairs, Quality Unit

5) Laboratory personnel

6) Clinical Trial Sponsors

FDA Inspection Preparation(圖7)-速報App