Clinical Process Improvement
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia &UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.
In 2019 she opened her own company, McElroy Training, and Consultancy, LLC which provides consultants for various projects as well as on and off-site training to pharmaceutical and biotech companies throughout the United States.
Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams through implementing 5 simple techniques she has learned and applied through the years.
Effective process improvement can be key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, the contract research organization (CRO) level or the institutional review board (IRB) level can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in clinical trials – sponsors, CROs and IRBs – take steps to improve both efficiency and accuracy.
- Discuss evolving challenges with different phases of clinical studies for Sponsors, CROs, third-party vendors and sites
- Define areas in clinical research which need to maintain high-quality standards and discuss the Need for Improvement
- Understand the quality improvement process and strategies
- Discuss how to optimize the process and improve efficiency and quality of research conducted (continuous quality improvement)
- Address strategic planning and budgetary consideration
- Determine critical factors for selecting and training clinical trial sites, vendors, contractors
- Plan, develop and implement effective process improvement and study management strategies
Course Level - Intermediate
Who Should Attend
- Directors of Clinical Operations
- Medical Affairs specialists and leaders of this division
- Project Managers
- Staff from Pharmaceutical/Device Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
- New clinical or other Project Team Leaders who will be managing projects
- Clinical, Regulatory, Research, and Department (R&D) Staff who will design clinical trial programs
- Physician investigators
- Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs), Data Managers or others working in biomedical product development and/or interested in transitioning into clinical trials field
- Grant Administrators
- Regulatory Affairs
- Quality Control(QC), Quality Assurance Specialists
Why Should Attend
In this session, we will review the main principles, practices, and methodologies for implementing continuous quality improvement and risk-based management of clinical trials.