New GCP Compliance Requirements for Clinical QMS (Quality Management Systems)

Tuesday, March 12, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes          


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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.

Laura Brown   Product Id : 502377
  Instructor : Laura Brown

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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
    • Management review

Learning Objectives :
  • Understand clinical Quality Management Systems (CQMS)
  • Review the new proposed CQMS framework
  • Discuss the importance of Key Performance Indicators (KPIs) in your CQMS
  • Ensure compliance with CQMS expectations of inspectors

Who Will Benefit:
  • 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)
  • Consultants
  • 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)

Speaker Profile
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.

She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.

Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013). She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.

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