This course will provide guidance on best practices for conducting internal audits. You will learn how to conduct an internal audit. We will discuss the internal audit process from A to Z. We will explore strategies for dealing with common internal auditing issues.
This course clarifies the role of the Clinical Research Monitor and explains their responsibilities under the GCP guidelines. This course will also discuss interactions with others in key roles as part of the clinical trial as well as exploring some aspects of clinical trial monitoring.
Areas to be Covered:
Overview of Internal Auditing
What is Auditing?
What are the auditors’ responsibilities?
Planning the Audit
How to get started?
Writing the Audit Plan
Developing Audit checklists
What do I review before the audit?
What are the applicable regulations & standards?
Who should participate?
What am I looking for?
How do I find out what I need to know?
Interviewing and Gathering Evidence
Making the Auditee comfortable
What is an observations/finding?
How do I write my observation/findings?
Wrapping up the Audit
The closing meeting
Writing the audit report
Who will Benefit:
Clinical Research Monitors
Internal Auditors Beginners
Professionals planning to move into Internal Auditing