LDT Industry Education: Record Keeping and Adverse Event Reporting

Julie Ballard joined NDA Partners as an Expert Consultant in 2020. Ms. Ballard is a Clinical Laboratory Scientist with expertise in building new clinical laboratories and quality systems, regulatory compliance, laboratory operations and management, CAP and CLIA accreditation, and state regulations through the Laboratory Field Services (LFS) program in California and the Clinical Laboratory Evaluation Program (CLEP) in New York. In addition, she has experience launching novel high-complexity laboratory-developed tests including liquid biopsy-based next-generation sequencing and tissue-based gene expression profiling oncology tests, and phenotypic/genotypic HIV drug-resistance testing. Throughout her 25-year career, she has provided leadership and operational expertise to biotechnology startup companies, including her recent position as Senior Director of Clinical Laboratory Quality at Seer, Inc. She also served in Clinical Laboratory and Quality Director positions at GRAIL, Guardant Health, TOMA Biosciences, and Genomic Health.

Bobbi Druyor-Sanchez, MS, is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2014. She is a bioengineer with expertise in both regulatory affairs and quality assurance with area of emphasis being software as a medical device (SaMD), telemedicine, ophthalmic, and supporting the convergence of CLIA based Laboratory Developed Tests (LDT) to FDA in vitro diagnostic tests including bioanalytic implementation. This includes defining technical and product direction in early-stage companies, 510(k) and De Novo clearance submissions, implementing medical device quality systems including QSR, ISO 13485, and MDR/CE Mark Certification Quality Management Systems.

Alberto Gutierrez, PhD is a Partner and has worked with the company since 2017. He is an expert in preclinical and clinical testing of in vitro diagnostic and radiological imaging devices, premarket notifications of devices, applications for approval, and post-marketing surveillance and compliance. Dr. Gutierrez oversaw the Personalized Medicine Staff at the FDA and developed and managed the policies surrounding companion diagnostic devices and was a member of the Center for Devices and Radiological Health (CDRH) committee that oversaw policies on Digital Health.

Dr. Hartzfeld joined NDA Partners as an Expert Consultant in 2019. She is a quality assurance expert with 25 years of experience working in scientific research and FDA-regulated environments including pharmaceutical, medical device, biologics, and combination products.
Dr. Hartzfeld has experience in all aspects of quality, laboratory, manufacturing, and regulatory requirements for FDA, MDR, IVDR compliance, including QA/QC Systems development and implementation, analytical and microbiological laboratory and method controls, design controls, auditing, training, CAPA and complaint handling. She holds an auditor certificate for ISO 13485 medical device manufacturing standard. She is proficient at FDA inspection readiness planning and skilled in remediating FD-483/Warning Letters. She also performs trainings on Good Manufacturing Practices and conducts due diligence audits for business acquisitions in conjunction with law firms.