Agenda

Quality Management Conference

Day 1

8:30 to 9:00 am - Registration and Continental Breakfast

9:00 to 10:00 am - Keynote: Insights into Data Integrity and Technology Controls for Clinical Research (1.00 CE)

Devry Spreitzer, Sr. Director, Data Integrity Quality Assurance, Astellas Pharmaceuticals

Mr. Spreitzer will summarize the requirements for data integrity and technology controls pertinent to the clinical research and clinical sponsors and clinical investigator sites. Topics to be discussed include requirements and regulations for clinical data, validation of technology solutions used in clinical research, sponsor – site interactions to drive compliance, and a look at upcoming changes to ICH E6 R3 pertaining to data integrity

10:00 to 10:15 am - Break

10:15 to 11:15 am - International Conference for Harmonisation (ICH) Good Clinical Practice (GCP) – Looking Ahead to R3

Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
This brief session will prime the audience to contemplate how the upcoming ICH GCP R3 will impact quality management practices

Quality Management Systems (QMS): Design and Application (1.00 CE)

Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health

The objectives of this talk are to: 1) introduce the design of quality management systems in clinical research and 2) 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 (1.00 CE)
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? (1.00 CE)

Tammy Neseth, MA, CCRP, Senior Manager Site Services, Quantum Leap Healthcare Collaborative

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 Assessment in Clinical Research: A Primer (1.00 CE)
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 (0.50 CE)

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 (0.50 CE)

Course Faculty

Day 2

8:30 to 9:00 am - Registration and Continental Breakfast

9:00 to 10:00 am - Impact of Systemic Non-Compliance (1.00 CE)
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 (1.00 CE)

Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center

Jessica Rowe, MA, MS, CCRP, CIP, Director of Quality and Education, Clinical Trials Office, Yale Cancer Center

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 (1.00 CE)

Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center

Jessica Rowe, MA, MS, CCRP, CIP, Director of Quality and Education, Clinical Trials Office, Yale Cancer Center

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 2:15 pm - - Emotional regulation techniques for the quality professional: techniques to support personal and team performance (0.75 CE)

Greg Staios, MSc, CCRP, Professor, Seneca College, School of Biological Sciences and Applied Chemistry, Clinical Research Program

o This session will provide attendees with strategies that will enable them to recognize when stress may be impacting themselves, their teams, and those they support in achieving quality outcomes. Techniques that could be utilized to reduce stress through both sustained or “in the moment” practices will be described.

2:15 to 2:45 - Breakout Sessions: CAPAs and FDA FORM 483 Responses (0.50 CE)
Attendees will break out into smaller groups to participate in exercises discussing corrective action plans (CAPAs) and FDA Form 483 responses.

2:45 to 3:45 pm - Using QA and QC trends to Drive Education and Training (1.00 CE)

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.

3:45 to 4:45 pm - Interactive panel discussion – Quality Assurance Career Development & Culture (1.00 CE)

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 (0.25 CE)

Course Faculty

Agenda

Quality Management Conference

Day 1

Day 2

Quality Management Live Program