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ROCHELLE, Va., July 24, 2019 NDA Partners Chairman Carl Peck, MD, announced today that Donna Hartzfeld, PhD, a quality assurance expert with more than 20 years of experience working in scientific research and FDA-regulated environments including pharmaceutical, medical device, biologics, and combination products, has joined the firm as an Expert Consultant.
Dr. Hartzfeld has experience in all aspects of quality, laboratory, manufacturing, and regulatory requirements for FDA compliance, including device and drug QA/QC Systems development and implementation, analytical laboratory and method controls, validation, document controls, warehouse and process controls, supplier/vendor management, design controls, auditing, training, and due diligence. She holds an auditor certificate for ISO 13485 medical device manufacturing standard and is proficient at FDA inspection readiness planning and FDA 483/Warning Letter remediation activities.
Dr. Hartzfeld was formerly the Quality Assurance Director at OrthoLogic, where she managed quality assurance activities for a clinical-stage wound healing drug product. She was a senior consultant with the National Science Foundation Health Sciences Pharma Biotech Consulting, Quintiles Consulting, Marion Weinreb & Associates, and Precision FDA Consultants.
"We are very pleased to welcome Dr. Hartzfeld to NDA Partners," said Dr. Peck. "Her expertise in quality assurance, in addition to her experience working in FDA-regulated environments, will benefit our clients who are developing pharmaceutical, medical device, biologic, and combination products."
Dr. Hartzfeld earned a doctorate degree in chemistry and a bachelor's degree in chemistry and biology from Arizona State University. She is a member of the American Society of Quality, Regulatory Affairs Professional Society, and the Arizona BioIndustry Association.
About NDA Partners NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 MartinEarle(at)ndapartners(dot)com
SOURCE NDA Partners LLC
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Dr. Hartzfeld has experience in all aspects of quality, laboratory, manufacturing, and regulatory requirements for FDA compliance, including device and drug QA/QC Systems development and implementation, analytical laboratory and method controls, validation, document controls, warehouse and process controls, supplier/vendor management, design controls, auditing, training, and due diligence. She holds an auditor certificate for ISO 13485 medical device manufacturing standard and is proficient at FDA inspection readiness planning and FDA 483/Warning Letter remediation activities.
Dr. Hartzfeld was formerly the Quality Assurance Director at OrthoLogic, where she managed quality assurance activities for a clinical-stage wound healing drug product. She was a senior consultant with the National Science Foundation Health Sciences Pharma Biotech Consulting, Quintiles Consulting, Marion Weinreb & Associates, and Precision FDA Consultants.
"We are very pleased to welcome Dr. Hartzfeld to NDA Partners," said Dr. Peck. "Her expertise in quality assurance, in addition to her experience working in FDA-regulated environments, will benefit our clients who are developing pharmaceutical, medical device, biologic, and combination products."
Dr. Hartzfeld earned a doctorate degree in chemistry and a bachelor's degree in chemistry and biology from Arizona State University. She is a member of the American Society of Quality, Regulatory Affairs Professional Society, and the Arizona BioIndustry Association.
About NDA Partners NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 MartinEarle(at)ndapartners(dot)com
SOURCE NDA Partners LLC
