Audit and Inspection Readiness - Series of Webinars

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Audit and Inspection Readiness – Series of Webinars

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Date	Product	Location	Price
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. We will show you 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.

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):

15 June 2020: Introduction (13:00 to 14:30)
- Introductions and way of working remotely
- Inspection: what - why - who - where - how?
15 June 2020: Inspection Process (15:00 to 16:30)
- Inspection process and FDA inspection
17 June 2020: Communication (09:00 to 10:30)
- Communication during the inspection
17 June 2020: Conclusion (11:00 to 12:30)
- 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)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Trainers

Ms. Liesbeth Lemmens

Trainer