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2006 年 03 月 13 日 9:00 上午 - 2050 年 12 月 31 日 12:00 上午

Strategies for Good Clinical Practice Audits

概览

Learn basic knowledge of Good Clinical Practice audit programs and strategies.  This online course is designed to help you with types of audits and inspections, audit reporting, general procedures in preparing for a FDA inspection, role and findings of FDA inspections and how to successfully handle and respond to a FDA inspection. 
Course Level: Beginner

内容纲要

  • Audit programs and strategies
  • Role of the audit
  • Audit preparation, managing and follow-up
  • FDA audits, outcomes and follow-up

谁应该参加？

  • Clinical research associates
  • Quality assurance auditors
  • Data management professionals
  • Medical writers
  • Regulatory affairs professionals

学习目标

At the conclusion of this activity, participants should be able to:

  • Describe the quality assurance audit process
  • Strategically plan, prepare for and organize a GCP inspection
  • Recognize the various type of audit programs and strategies
  • Manage the GCP audit process and how to ensure a successful outcome
  • Handle and successfully respond to FDA inspection findings

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