Eye and Tissue Resources is an umbrella company of partners who collaboratively provide wrap-around services in blood, tissue, eye, and organ transplantation. The major categories of services provided include: Online CEUs, Quality Consulting and Training, Auditing, Medical Director (tissue banks and organ procurement organizations), and FDA Regulatory services (361 vs 351 HCT/P, combination products including HCT/Ps, other IND/BLA).
Meet Our Team!
Dr. Michael Bauer enrolled in the Loma Linda University School of Medicine in 1988. After graduation from medical school, he completed a residency in pathology in 1997 at the same institution, followed by a fellowship year in Blood Banking and Transfusion Medicine at Cedars-Sinai Medical Center in Los Angeles. Dr. Bauer is board certified in Clinical Pathology and Transfusion Medicine. He served in Michigan, New Jersey, and Colorado as a blood bank physician. Since beginning a private laboratory consulting practice in September of 2000, Dr. Bauer has grown MJB and Associates to one of only a handful of practices that offers CLIA-qualified laboratory directors to clinical laboratories across the United States. He and two other physicians in his practice are CLIA-qualified laboratory directors, licensed in most states, and eligible for licensure in all others. His practice also provides general laboratory consulting and physician of record services.
Darla Torkelsen, MS, brings over 20 years business experience, which includes consulting and creating online CEU opportunities. She is the executive director of Eye and Tissue Resources.
Jennifer Drago is the Executive Director of Advanced Quality Resources (A division of Eye and Tissue Resources), a Quality Systems Consulting firm and a Quality Auditor. She has previously worked as a Quality Systems Manager at an Organ and Tissue Recovery Agency. She received a B.S degree in Physical Science from Kansas State University. She has over 10 years’ combined experience in Quality and Regulatory Affairs in Blood Banking, Medical Devices, and Tissue & Organ Procurement. Jennifer is a Certified Tissue Bank Specialist (AATB), Certified Quality Auditor (ASQ) and a Certified Manager of Quality and Operational Excellence (ASQ). She also has her Six Sigma Yellow Belt Certification and was a Six Sigma White Belt Trainer. She is the Vice-Chair for the AATB Quality Council.
Dr. Melissa Greenwald is a 1997 graduate of the Uniformed Services University School of Medicine. She trained in internal medicine at Bethesda Naval Hospital, and was board certified in 2000 and 2010. Dr. Greenwald worked at FDA in the Center for Biologics between 2000-2014 when she departed as the Chief, Human Tissue and Reproduction Branch, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies. At FDA, she was involved in finalizing the 1271 regulations, was the champion for all guidance documents and policy related to screening tissue and cell donors, and was the lead scientific reviewer for all infectious disease donor screening assays with an indication for use with testing organ, tissue and cell donors. Dr. Greenwald worked at the Health Resources and Services Administration, Division of Transplantation between 2014 and 2018, where she served as the Director of the Division of Transplantation between October 2015 until retiring from Active Duty in March 2018. Throughout her career, Dr. Greenwald has worked closely with all stakeholders throughout the tissue, organ, and cell communities worldwide. She has expertise in national program development and administration, policy development, and regulatory-related research and document preparation. MA Greenwald Consulting provides consultative services in all areas of tissue and organ transplantation, including regulatory consultation on multiple aspects of FDA tissue and biologics regulations, physician of record service, and as a medical/scientific advisor.
Contact Information: firstname.lastname@example.org or Phone: 1-503-704-4356