Standard Operating Procedures (SOPs) Development and Implementation
Donna Headlee, RN, BSN, CCRP
Donna Headlee is the Premarket Programs Branch Chief, Division of Industry and Consumer Education (DICE), in CDRH's Office of Communication and Education. In this role, Ms. Headlee leads the branch in the development of medical device industry education on premarket issues and the Small Business Determination (SBD) program. She joined FDA in 2004 as a Consumer Safety Officer with the Office of Compliance (OC), Division of Bioresearch Monitoring in the Special Investigations Branch. In 2009, she joined the Premarket Application Section of the Program Operations Staff, in the Office of Device Evaluation. She joined DICE in February 2016.
Prior to her FDA career, Ms. Headlee served as a Research Nurse Coordinator at the National Institute of Health (NIH), with the National Cancer Institute (NCI), where she served as a Research Coordinator for Phase 1 oncology clinical trials. Ms. Headlee received a Bachelor of Science Degree in Nursing from Salisbury State College and a Masters Certificate in Regulatory Compliance from Hood College.
Joanne Goldberg, MSc, pht, CCRP
Joanne Goldberg, MSc, pht, CCRP, is the Assistant Director of the Canadian Institutes of Health Research’s Institute of Aging in Montreal, Canada. She holds a Master of Science degree in Biomedical Sciences from the University of Montréal as well as a Bachelor of Sciences degree in Physical Therapy from the same institution. She has been involved in clinical research for the past 18 years and has held many positions including Associate Director of Scientific Affairs, Director of Training, Director for Clinical Site Network Management, Director of Quality Management Systems, Senior Project Manager, Senior Study Coordinator, as well as Investigator. Her expertise is primarily in the development and implementation of international partnerships for health research as well as quality management systems, training in Good Clinical Practices, study methodology, and writing and implementing standard operating procedures. She is responsible for the French language translation and administration of the Society of Clinical Research Associates’ (SoCRA) certification examination and Preparatory Course. Joanne is a member of the SoCRA Certification Committee and is a Past President of the Society.