Quality Management

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2023 Agenda

Saturday, September 30, 2023 at 8:30 to 9:15                                                                                                            Track: Quality Management

The Journey of Achieving a Quality Research Program Through Required Education and Training

This presentation will provide information about establishing a new departmental education program including a new employee orientation and robust competency program. 417
Presenter: Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Educatio, Vanderbilt University Medical Center

Saturday, September 30, 2023 at 9:20 to 10:05                                                                                                   Track: Quality Management

The Road from Compliance to Quality in Clinical Trials

The transformation of a clinical trials compliance program to a quality assurance program presents substantial challenges. From reorienting the stakeholders to practical issues such as title and role changes and developing new worksheets, there are many things to consider in the effort to improve oversight of studies. A successful quality assurance program offers a much more satisfying experience for the entire clinical trials team. 419
Presenter: Eileen Healy, MS, CCRP, Clinical Research Quality Assurance Coordinator, Roswell Park Comprehensive Cancer Center

Saturday, September 30, 2023 at 10:50 to 11:35                                                                                                     Track: Quality Management

Notes to File: Compliant Practices and Ensuring Data Integrity

This Note to File (NTF) presentation will review what an NTF is, current practices, and current problems as well as Quality System oversight. Lessons learned from audits and the use of NTFs will also be presented. 421
Presenter: Heather Pham, MS, CCRP, CHRC, Clinical Research Educator, Providence St. Joseph Health

Saturday, September 30, 2023 at 11:40 to 12:25                                                                                             Track: Quality Management
Analysis of Quality Challenges in Phase I and II in Cellular and Gene Therapies

Dr. Soans will compare quality challenges seen in FDA approved cellular and gene therapies in the market to early phase development products at St. Jude. We will look at how we have responded to FDA Information requests on quality and time taken from pre-IND stages to IND submissions and what have been the limitations. 423
Presenter: Eroica Soans, PhD, CCRA, Senior Medical Writer, St Jude Children's Research Hospital

Saturday, September 30, 2023 at 1:40 to 3:15                                                                                                Track: Quality Management 

A Quality Improvement Program in Human Subject Research

As research monitoring and compliance paradigms evolve, human subject research teams are challenged to ensure that quality in research maintains or exceeds expectations and standards. 425/427
Presenter: Jennifer Dolan, MS, LMT, CCRC, Specialist, Research Quality Improvement, University of Rochester
Presenter: Kathleen Wessman, MPA, RN, RQAP-GCP, CCRC, Director, Research Quality Improvement, University of Rochester
Presenter: Elizabeth Lyda, BS, RRT, Research Quality Improvement Specialist, University of Rochester