Introduction to the Audit Process elearning

RQA Member: USD ($) 134.00
Non-Member: USD ($) 174.00

Your Price: USD ($) 174.00

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Please note payment is required before access is given. However, if you need earlier access to the eLearning please contact elearning@therqa.com.

Course Introduction

The course is made up of nine learning modules and is intended to provide an introduction to the audit process.

The course includes

• An understanding of the aims of the audit
• Identifying how to initiate the audit
• An understanding of how to effectively conduct document review
• Preparation for on-site audit activities
• How to perform on-site audit activities
• An appreciation of the requirements of preparing, approving and distributing the audit report
• How to complete an audit and conducting audit follow up
• Identifying trends, performing root cause analysis and considering corrective and preventive action.

Certificate

Once you have successfully completed the assessment (80% pass mark), you will be shown your pass mark and percentage and will then be asked to complete your details to generate a PDF certificate (displaying the CPD points gained) which you can download or print for your records.

Course Author

Louise Handy is now the Director of Handy Consulting Ltd, and has previously held senior positions across the breadth of the drug development and scientific research industry. Originally a research immunologist, she became CEO of a contract clinical research organisation and was Head of Quality & Regulatory Affairs for an injectable pharmaceutical manufacturer. Louise is the current Chair of the RQA and a member of the Institute of Clinical Research and the Chartered Management Institute. She works across all the GxPs, has been an EU QP for Pharmacovigilance, has been responsible for developing guidelines for Good Research Practice and has an international reputation in Good Clinical Laboratory Practice.

Corporate Licences

Multi-user licences for corporate use are also available, please click here for prices and further information.

CPD Points

4 points

Course Demo

Click here for demo (website registration/login required).

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Booklets

A Monitor’s Guide to Investigator Site Audits
Guide to the Role and Responsibilities of GLP Management
Hosting an External GLP Inspection

Courses

P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P21 Audit Programmes and Risk Assessment
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP21 Audit Programmes and Risk Assessment REMOTE LEARNING
RP22 Risk Management in Clinical Trials REMOTE LEARNING

Webcasts

Webcast - Audit Programmes: The Basics
Webcast - Where Does Audit End?