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.

Featured topics

Regulatory Framework EU and ICH Region and Quality Management
Inspections by European and Third Country Authorities
Trial Audit
Quality Management Processes
eTMF System
Sponsor Responsibilities and Oversight of the eTMF Management
Data Integrity, Data Governance System, GDPR Compliance
Critical Findings

Who should attend?

This course is designed for professionals in academia and in the pharmaceutical, medical and biotechnology industries who are responsible for:

Clinical operations representatives
CROs, CMOs and service providers
Document and records managers
Internal/External Auditing
Clinical Project Management
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
Realize how to ensure the organisation can remain inspection-ready at all times
Assess the differences between the FDA, EMA, MHRA and other national authorities
Determine the impact of GDPR has 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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