Internal Auditing – What you need to know



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?
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

Marie Dorat

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance