Compliance Trainings, Online
2015-08-18
Description : 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 Covered in the Session : 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? Opening Meetings The Audit Opening Meeting Who should participate? What am I looking for? Auditing techniques How do I find out what I need to know? Interviewing and Gathering Evidence Making the Auditee comfortable Questioning Techniques 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
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