MCC Announces — Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2), Free Webinar, Oct. 18, 2018

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Sep 28, 2018, 19:30 ET

FALLS CHURCH, Va. (PRWEB) September 28, 2018 -- Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)
**MCC Free Webinar**
Oct. 18, 2018 — 11:00 a.m. – 12:00 p.m. ET
http://info.fdanews.com/retooling-risk-based-quality-mngmnt-approaches-era-ich-e6r2

Are the scale, complexity and costs of clinical trials increasing?

Since the release of the ICH GCP Guidance updates, the answer is most likely yes.

Many sponsors and their partners have limited experience with risk-based quality management approaches.

On Oct. 18, Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will discuss approaches sponsors are taking to align with ICH E6(R2).

During 60 fast-paced minutes Linda and Keith will:

  • Explore new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • Discuss the importance of critical thinking in risk assessment and risk control
  • Explain the meaning of high and low detectability and the relevance to risk prioritization
  • Describe leading practices to improve risk assessment and quality oversight

Trial sponsors have to develop and implement risk-based quality management programs to comply with ICH E6(R2). Discover how during this free webinar.

Meet the Presenters:
Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium
Ms. Sullivan is Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations improve processes to improve financial and quality outcomes.

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd
Keith Dorricott has a background in manufacturing from Kodak Ltd. He has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma and is an expert in root cause analysis. He acts as facilitator for the MCC work groups including Vendor Oversight and Centralized Monitoring.

Who Will Benefit:
This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Clinical Operations/Management/ Research/Development
  • Clinical Outsourcing/Vendor Management/Third-Party Management
  • Clinical/Project Operations
  • Performance Analytics/Management/Reporting
  • Metric Reporting/Visualization
  • Quality Management/Clinical Quality Management
  • Compliance/Clinical Compliance/ Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Risk Assessment
  • Centralized Monitoring / Risk-based Monitoring
  • Good Clinical Practices
  • Clinical Process Optimization
  • Vendor Oversight

Webinar Details:
Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)
**MCC Free Webinar**
Oct. 18, 2018 — 11:00 a.m. – 12:00 p.m. ET
http://info.fdanews.com/retooling-risk-based-quality-mngmnt-approaches-era-ich-e6r2

Easy Ways to Register:
Online: http://info.fdanews.com/retooling-risk-based-quality-mngmnt-approaches-era-ich-e6r2
By phone: 888-838-5578 or 703-538-7600

About MCC:
Leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. Founded in 2006, MCC is the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. MCC provides the collaborative environment for biopharmaceutical and device sponsors, service providers and sites to improve clinical-trial development through use of MCC standardized performance metrics.

Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7660, [email protected]