TMF Inspection Readiness in Digital Era
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.
- 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
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
Regulatory compliance specialists.
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