This session addresses ways to control your recovery or processing environment (i.e. temp/humidity control, cleaning protocols and validations, use of PPE, use of sterile supplies/equipment, etc.), as well as ways to monitor the environments (i.e. recovery site assessment, periodic culturing, passive and active monitoring, etc.)
- Summarize the regulatory requirements and definitions for tissue environmental controls and monitoring.
- Understand how environments can be controlled.
- Explain routine environmental monitoring methods and periodic requalification methods of tissue recovery and processing environments.
- Recognize some “best practices” for ensuring a robust Tissue Environmental Monitoring Program.
Kelly Patrick graduated with honors from the University of Cincinnati in 2003 with a BFA in Electronic Media. She started working immediately for U.S. Tissue and Cell in Cincinnati, Ohio in July of 2003 as a Tissue Processing Technician. She became a Processing Supervisor in 2005 and continued in this position until U.S. Tissue and Cell was restructured in 2006. Kelly relocated to Dayton, Ohio and began working for Community Tissue Services (CTS) in April of 2006. CTS employs nearly 600 employees nationwide and distributes over 500,000 life-saving and life-enhancing tissue grafts each year. Kelly worked briefly as a Tissue Processing Technician before advancing into the Production Planning department. She spent a little over 5 years working in Production Planning where she reviewed donor information and created processing instructions for each donor in order to maximize the gift of donation and meet the needs of over 1300 customers worldwide.
Kelly transferred to the Quality/Regulatory Affairs department in April of 2012 where she initially supported CTS’s Manufacturing department. Kelly began supporting CTS’s Recovery department in 2014, along with CTS’s Microbiology Testing Lab. She currently approves new and revised procedures for Recovery and Microbiology operations, including those that involve Recovery’s environmental monitoring program. She also drives continuous improvement and CAPA opportunities, performs dozens of internal and external audits, and works to maintain both internal and regulatory compliance.
Kelly earned her Certified Tissue Banking Specialist certification through the American Association of Tissue Banks (AATB) in 2005 and has retained this certification to date. She has worked on several AATB committees and workgroups that review and improve tissue banking standards. She was also a presenter at AATB’s Quality Workshop in Atlanta, GA in 2015, speaking on the topic of Supplier Qualification programs, and also spoke at the 2017 Pharma Conference on the topic of environmental monitoring programs.
Kelly is currently pursuing her Master’s of Science Degree in Regulatory Science from the Johns Hopkins University
Environmental Controls & Monitoring
Speaker: Kelly Patrick
Day: April 11, 2018
Time: 2:00 p.m. - 3:00 p.m. EST