Audit and Inspection Readiness – Series of Webinars
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No sessions planned as this time, however if you are interested in taking this course please contact us at info@eccrt.com |

About this course
Is your institution faced with an audit/inspection and you want to prepare the team? If so, then this course is ideal for you. Join us in our Audit and Inspection Readiness Webinars to know what to do before, during and after the actual audit/inspection and how to respond to the audit/inspection report.
These 4 webinar sessions are designed to provide a basic understanding of the audit or inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful audit outcome. Audits and inspections are a fact of life when running clinical trials. This course will provide delegates with advice on the differences between audits and inspections, preparing and providing information to audits/inspections, workshops to improve communication and advice on how sites respond to audit/inspection findings. Read this article for more information.
- 30 October – 14h to 15h30
- 30 October – 15h45 to 17h15
- 03 November – 10h30 to 12h
- 03 November – 13h to 14h30
Programme highlight
This webinar course is composed of 4 sessions. Here is an overview of the webinar agenda (time of each session is under Brussels zone, GMT+01):
- Session 1:
- Introductions and way of working remotely
- Inspection: what - why - who - where - how?
- Session 2:
- Inspection process and FDA inspection
- Session 3:
- Communication during the inspection
- Session 4:
- Results of an inspection
- Fraud and misconduct
- Q&A - Wrap-up
Learning objectives
- Understand how audits and inspections are conducted
- Get hands-on information about how to prepare the team and documentation for a smooth audit/inspection
- Get an overview of applicable standards
- Know the data and document requirements specific to audits/inspections
- Know how to prepare for sponsor/CRO and sites audits/inspections
- Recognise continuous high-quality standards as a method of ensuring data quality
Who should attend
Clinical research professionals who are faced with an audit or inspection. Quality and project managers who have to guide their team through the audit and wanting to know what to do before, during and after an inspection or audit.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (1)
- Data Management and Informatics (2)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
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