Quality Thinking in Living Donation

Quality is quality, but there are different considerations for quality assurance in living donation. During this session, we will review the development and launch of birth tissue quality assurance programs.

Faith Case, MSQA, CTBS

Faith Case has served in the tissue bank industry since 2007 with a primary focus on quality systems. She is the Director of Quality Assurance, Risk & Safety at Regenerative Biologics, Inc. (formerly known as Southeast Tissue Alliance, SETA) a tissue recovery and acquisition agency in Gainesville Florida.

Faith has committed her career to continuous improvement, challenging the fundamental quality of people, processes, and products to achieve superior performance outcomes. She advocates creating cultures that promote continuous learning and process improvement. Recognizing and honoring the gift of donation, Faith is committed to maintaining the integrity of donors and raising awareness of the importance and benefit of donation.

Juan Rojas, CTBS

Mr. Rojas is the Vice President of Quality Systems at UMTB Biomedical. He has over 10 years of experience in manufacturing, validations, project management, and quality assurance in the device, pharmaceutical, biologics, and tissue banking fields. He started his career in 2007 at Bioheart where he played a key role to startup their GMP facility and manufacture the cell-based biologic product for phase III clinical trials. From Bioheart, Mr. Rojas was recruited to Biotest Pharmaceuticals to perform the upscale of a monoclonal antibody product for use in phase III clinical trials. In 2009, Mr. Rojas joined Bio-Tissue where he supervised and expanded their manufacturing department prior to assuming the role of the project manager for the organization. In 2013, he joined the diabetic device company Nipro Diagnostics as a Validations Engineer and managed the project portfolio for the Operations division. Shortly after in that same year, Mr. Rojas joined UMTB first as a consultant in the capacity of Program Director and later became the Vice President of Operations for the company. In 2016 he became the Vice President of Quality Systems for UMTB Biomedical and has been responsible for hosting and responding to multiple audits as well as the continuous process improvement of the quality systems in the organization.