TMF Management, Oversight and Inspection Experience

NEW OFFERING! This course teaches you oversight strategies for ensuring that you can sustain your inspection readiness throughout the clinical trial development process.

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Overview

For many organisations, clinical trial regulatory inspections are obligatory for achieving or maintaining market authorisation. However, it can be challenging for your organisation to sustain the required level of preparedness while simultaneously dealing with data integrity, data privacy and Good Clinical Practice (GCP).

This course teaches you oversight strategies for ensuring that you can sustain your inspection readiness throughout the clinical trial development process. Using practical examples, we will provide insights into helping your organisation prepare for an inspection in this digital era.

We will also show you those areas of quality, data integrity and process improvement where you should focus your attention if you are to be ready to meet specific EMA, FDA and MHRA requirements.

Who should attend?

This course is designed for professionals in the pharmaceutical, medical and biotechnology industries as well as academia:
- Clinical operations representatives
- CROs, CMOs and service providers
- Document and records managers
- Clinical Project Management
- Internal/External Auditing
- Trial Master Files
- Clinical Documentation Management
- IT and support personnel
- Quality assurance and compliance professionals
- Regulatory operations representatives
- Standards implementation specialists and associates
- Validation professionals
- Regulatory compliance specialists

Learning objectives

On completing this course, participants will be able to:
- Identify the key areas of focus for inspections
- Discuss how to ensure the organisation can remain inspection-ready at all times
- Compare the differences between the FDA, EMA, MHRA and other national authorities
- Identify the impact of GDPR on managing Clinical Trials and establish Data Integrity
- Apply a risk-based approach to planning and conducting internal audits

Digital Learning Catalog

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