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Webinar: When Navigating Risk in Clinical Trials, It’s Best to Mind Your CTQs and QTLs

Recorded Tuesday, February 18, 2020  |  11:00am – 12:00pm EST


The clinical trials industry is filled with a multitude of acronyms. Deciphering them, making sense of regulations, and understanding semantics – in an industry that often does not speak precisely – can be a challenge.

ICH E8 (R1) was released for comment from May through October 2019. This revision to general considerations for clinical trials was triggered by ICH E6 (R2) with the intent to provide updated guidance that is appropriate and flexible to address the increasing diversity in the design and data sources employed in today’s clinical trials while preserving foundational principles supporting human subject protection and data quality.

This webinar focuses on the Quality Tolerance Limit (QTL) requirements of ICH E6 (R2) while addressing the intersect of Section 3 of ICH E8 (R1), where specific focus is given to proactive quality-by-design in clinical trials, including identifying and managing critical-to-quality factors (CTQs).


Learning Objectives:

  • Outline regulatory requirements from E6 and E8 that pertain to CTQ and QTL factors
  • Define CTQs and QTLs, with case examples of each
  • Discuss the intersection of CTQs and QTLs


This webinar is ideally suited for:

  • Quality Assurance/Quality Control/Quality Compliance/Quality Management
  • Clinical Operations/Research/Planning
  • Clinical Outsourcing and Development
  • Trials Management/Research
  • Global Compliance
  • Safety and Risk Management Operations
  • Internal/External Auditing
  • Training, GCP, GVP
  • Clinical Project Management
  • Trial Master Files
  • Clinical Documentation Management
  • Global Regulatory Affairs
  • Process Optimization


Presented by:

Crissy MacDonald

Executive Director, Client Delivery

The Avoca Group

As leader of the Avoca Group’s Integrated Consulting and overseer of the Avoca Quality Consortium workstreams, Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Crissy earned a PhD in biomedical engineering from Drexel University and a bachelor’s degree from Lafayette College.