Inspection Readiness for CRAs and PMs - Webinar

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Inspection Readiness for CRAs and PMs – Webinar

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Date	Product	Location	Price
20/05/2022	Inspection Readiness for CRAs and Project Managers	Webinar	EUR 210.00	Book
17/10/2022	Inspection Readiness for CRAs and Project Managers	Webinar	EUR 210.00	Book

About this course

Reasons to attend

Audits and inspections are a fact of life when running clinical trials. This course is designed to provide a basic understanding of the inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome. This Inspection Readiness for CRAs and PMs webinar will fulfill your expectations in a very practical way. It is an interactive approach to comprehend and prepare inspections, and you can learn at your own pace.

What's included?

Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been granted PharmaTrain Recognition

Course schedule

Live online training: 2h (14h00 – 16h00)

Course Description

Does your institution and team want to be prepared for an (upcoming) inspection? If so, then this course is ideal for you. We will show you what to do before, during and after the actual inspection and how to respond to the inspection report.

It is designed to provide a basic understanding of the inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome.

This Inspection Readiness for CRAs and PMs webinar will provide delegates with advice on the differences between audits and inspections, preparing and providing information to inspections, tips how to improve communication and advice on how sites respond to inspection findings.

This course will fulfill your expectations in a very practical way. It is an interactive approach to comprehend and prepare inspections, and you can learn at your own pace.
Read this article for more information.

Programme highlight

Inspection concepts (FDA, EMA, regulatory authority)
Current inspection standards
Different approaches to preparing and participating investigator site inspection
Responding inspection findings

Learning objectives

Be able to differentiate between audits and inspections
Learn how to prepare and provide information to inspectors
Learn how to improve communication
Advice on how to respond to inspection findings

Who should attend

Clinical Quality and Compliance Professionals
Clinical Research Associates
Project Managers
Clinical Research Coordinators
Clinical Principal Investigators
Ethics committees and their Members

Competencies

This course covers competencies that are part of the ECCRT Competency Framework:

Scientific Concepts & Research Design ()
Ethical & Participants Safety Considerations ()
Investigational Product Development and Regulation ()
Clinical Studies Operations (GCPs or ISO 14155) ()
Study and Site Management ()
Data Management and Informatics ()
Leadership and Professionalism ()
Communication ()
Teamwork ()
Business acumen ()

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