Audit and Inspection Readiness – How to be prepared!
About this course
Reasons to attend
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.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions |
Course Description
This Audit and Inspection Readiness course is designed to provide a basic understanding of the audit or inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance of ensuring good data quality, as a basis of successful audit outcome. Audits and inspections are an inevitable part of 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
- Assign the right persons for the audit/inspection stage and support
- Prepare the documentation
- Prepare the team
- How to present non-compliances that occurred during trial conduct
- Technical hints and tips for right behaviour.
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
This course is designed for 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)
Trainers
Marieke Willemse
Erasmus University Medical Center
Mona Frey
Gouya Insights
Anonymous