2023 Agenda - 2024 Agenda Coming Soon!
8:30 to 9:00 am Registration and Continental Breakfast
9:00 to 10:00 am Keynote Speaker: Agility, Critical Thinking, and Scale in Risk Based Quality Management Frameworks
Michael Torok, PhD, Vice President, Global Head of Quality Assurance Programs at Roche
Dr. Torok will share a cross-functional model detailing the essential focus areas, building blocks, and cultural elements that underpin successful quality assurance practices.
10:00 to 10:15 am Break
10:15 to 11:15 am Quality Management Systems (QMS): Design and Application
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
Dr. Statler will introduce the design of quality management systems in clinical research and discuss how to apply the QMS principles when building a quality assurance program.
11:15 to 12:15 pm Training and Tools Used to Assess and Control Risk within Clinical Trial Project Management
Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty at Miami University
This session will detail best practices in assessing and mitigating risk in clinical trial project management. Review of professional tools and training pathways will be investigated to optimally equip teams.
12:15 to 1:15 pm Lunch
1:15 – 2:15 Can We Really Conduct this Study?
Tammy Neseth, MA, CIP, CCRP, Clinical Trial Monitor
This session will provide attendees an opportunity to discuss conducting a study from four specific viewpoints, all of which will ensure the site is able to comply with the protocol and meet quality requirements. Ms. Neseth will discuss the scientific, practical, financial, and ethical considerations of conducting a study to comply with protocol and quality requirements.
2:15 to 2:30 pm Break
2:30 to 3:30 Risk Mitigation Tactics : Assessments & Control
Greg Staios, MSc, CCRP, Professor, Seneca College, School of Biological Sciences and Applied Chemistry, Clinical Research Program
This presentation aims to highlight the key processes that can be undertaken and the tools that can be used to identify compliance hazards, within the context of clinical research.
3:30 to 4:00 Breakout Sessions: Risk Assessments
Attendees will break out into smaller groups to participate in exercises discussing risk assessments.
4:00 to 4:30 Day 1 Wrap up / Q+A
Course Faculty
8:30 to 9:00 am Registration and Continental Breakfast
9:00 to 10:00 am Impact of Systemic Non-Compliance
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
In this session, Ms. Wintering will define the different types of non-compliance, determine who non-compliance pertains to in clinical research, and identify some of the potential impacts of non-compliance. The attendee will be able to determine the difference between non-compliance and an error and identify strategies to avoid non-compliance.
10:00 to 10:30 am Break / Networking Event
10:30 to 11:30 am Audit/Inspection Readiness: Part 1: Inspection Readiness & Conduct
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center, Senior Advisor, Quality Assurance and Regulatory Research Initiatives, Yale Center for Clinical Investigation
Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, HRPP and Yale University, Center for Clinical Investigation, Regulatory Compliance & Quality
This session will cover the essentials of audit/inspection readiness, from pre-notification through close-out, including best practices for prospectively maintaining essential documents necessary for a successful audit/inspection. This session will also discuss audit/inspection conduct and offer tips and tools for successfully navigating audits/inspections.
11:30 to 12:30 pm Audit/Inspection Readiness: Part 2: Root Cause Analysis & Corrective and Preventative Action Plans
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center, Senior Advisor, Quality Assurance and Regulatory Research Initiatives, Yale Center for Clinical Investigation
Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, HRPP and Yale University, Center for Clinical Investigation, Regulatory Compliance & Quality
This session will build on the previous session, providing an in-depth discussion on conducting root cause analysis and developing corrective and preventative actions to address audit/inspection observations.
12:30 to 1:30 pm Lunch
1:30 to 2:00 pm Breakout Sessions: CAPAs and FDA Form 483 responses
Attendees will break out into smaller groups to participate in exercises discussing corrective action plans (CAPAs) and FDA Form 483 responses.
2:00 to 2:45 Instilling Quality in the Design and Use of Study Tools
Monika Schmuck, BSc, CCRP, Quality Assurance Specialist, University Health Network
The speaker will share two quality initiatives at an academic research centre, from planning to implementation. The Hands-On Quality program invites staff within the Research Program to conduct a “real-life” quality assurance review. The Study Tools Working Group consists of representatives from various research departments and meets monthly to review and provide feedback on study tools.
2:45 to 3:00 pm Break
3:00 to 4:00 pm Using QA and QC trends to Drive Education and Training
Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty at Miami University
This session will outline top QA and QC trends to elucidate ideal training and educational needs. It will help teams hone in on focus areas of interest to create efficiency and optimal performance.
4:00 to 4:45 pm Interactive Panel Discussion Quality Assurance Career Development & Culture
Course Faculty
This panel discussion will provide the audience with the opportunity to engage in dialogue with course faculty regarding all conference topics.
4:45 to 5:00 pm Conference Wrap up / Q+A
Course Faculty