概要

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

何を学ぶか

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

参加対象

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

学習目的

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

Strategies for Good Clinical Practice Audits

概要

何を学ぶか

参加対象

学習目的

最新情報や機会を逃さないで