Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based.
Regulatory inspectors including those in Europe, the FDA and UK's MHRA now expect a CQMS to be in place. However, there is no industry-wide conceptual framework for clinical Quality Management that aims to address quality and monitor and improve performance in complex clinical development-specific environments. More developed systems exist in other departments such as manufacturing and pharmacovigilance.
Organizations are struggling to implement the QMS standards such as ISO 9000 principles,ICH 10 for CQMS and also some ICH R2 CQMS requirements are proving challenging. Since there is currently no harmonized regulatory guidance defining elements of a CQMS framework there is a proposal for a new ICH guideline to cover CQMS.
This session is designed to help in both the compliance with inspectors expectations for CQMS and share best practice for CQMS including a new proposed unified standard CQMS framework.
Why should you Attend: This course is aimed at anyone working in clinical research and associated functions including regulatory affairs, document management etc who need to know how to establish, maintain, monitor and improve a modern CQMS that focuses on product quality, compliance to GCP and the needs of the business.
This course is also of value to any Quality Professional, especially those working in Quality Assurance and Quality Improvement roles in clinical research, management responsible for the governance of CQMS and anyone working with or in clinical research who needs to comply with the new requirements for CQMS including study sites.
It is ideal for those implementing a CQMS, those wanting to share best practice for CQMS and also anyone wanting to know about the new harmonized standard proposed for CQMS.
Areas Covered in the Session:
What is a Clinical Quality Management System?
Regulatory drive for CQMS: ICH Q10, EMA Quality Systems, ISO 900, ISO Devices, FDA perspective, ICH E6 (R2)
Proposed ICH CQMS - CQMS Framework
What are the components of a CQMS
Compliance Deficiencies including CQMS
What are inspectors looking for?
Feedback from the regulators - hot inspection topics and trends
Documentation supporting quality and Data Integrity in CQMS
What documents which should be in place?
Importance of Key Performance Indicators (KPIs) in your QMS
Governance of CQMS
The role of Senior Management
- Pharmaceutical/Biopharmaceutical/device managers, Directors working in GXP areas
- Clinical Research Managers, VPs and Directors
- Quality Assurance for clinical trials /GXP
- Study Site Staff
- CROs and other Vendors working on Clinical Trials
- Data Management
- Pharmacovigilance for Clinical Trials
- Information Security Managers
- Data Protection Officers
- R&D and Manufacturing Managers
- Managers (RA & CA)
- Contractors and Subcontractors
- Regulatory Managers/Personnel
- Manufacturing Managers, Supervisors & Personnel | Internal Auditors | Senior Management Executives (CEO, COO, CFO, etc.)
- Project Managers
- Clinical Affairs
- Quality Management (QA & QC)
• Pharmaceutical/Biopharmaceutical/device managers, Directors working in GXP areas
• Clinical Research Managers, VPs and Directors
• Quality Assurance for clinical trials /GXP
• Study Site Staff
• CROs and other Vendors working on Clinical Trials
• Data Management
• Pharmacovigilance for Clinical Trials
• Information Security Managers
• Data Protection Officers
• R&D and Manufacturing Managers
• Managers (RA & CA)
• Contractors and Subcontractors
• Regulatory Managers/Personnel
• Manufacturing Managers, Supervisors & Personnel | Internal Auditors | Senior Management Executives (CEO, COO, CFO, etc.)
• Project Managers
• Clinical Affairs
• Quality Management (QA & QC)