Stephanie Slater

STEPHANIE SLATER advises her clients on compliance and regulatory areas related to the manufacturing of pharmaceutical and biotechnology products. Leveraging over 11 years of government regulatory experience, she assists clients with their regulatory agency correspondences, performs mock U.S. FDA audits, and assists with quality system investigations and vetting of clients’ potential third-party service contractors. During the COVID-19 era, Stephanie became proficient with Remote Regulatory Assessments (RRAs) performed by the FDA under FDCA Section 704(a)(4) (also known as FDASIA Section 706), for both domestic and foreign pharmaceutical entities.

Prior to advising law firm clients, Stephanie worked as an investigator for the U.S. FDA in the Seattle, San Francisco, and Los Angeles Districts, and the Office of Pharmaceutical Quality Operations (OPQO) Division IV. She completed details for the FDA as a drug investigator for the India Office located at the United States Embassy in New Delhi, India, and as acting compliance officer and acting supervisory consumer safety officer for the OPQO Division IV. While at the FDA, Stephanie conducted inspections of pharmaceutical and biopharmaceutical products. Prior to joining the FDA, Stephanie worked for 10 years in academia and industry in clinical and GLP (good laboratory practice) settings.

Earlier in her career, Stephanie was a Drug GMP Investigator and a Drug Specialist for the FDA for 11 years. At the FDA, she led over 100 inspections, including those in drug and biologics manufacturing facilities located around the world. The facilities included manufacturers of non-sterile and sterile drug products, manufacturers of active pharmaceutical ingredients (APIs), compounding pharmacies and outsourcing facilities, and pharmaceutical testing laboratories. She completed multiple industry partnership trainings, including the U.S. FDA Biotechnology Partnership training through North Carolina State University, where upscale fermentation and bioreactor processes, as well as downstream purification processes, aseptic processing, and quality control laboratories were covered. While at the FDA, Stephanie also served as Acting Compliance Officer and Acting Supervisory Investigator. In these roles, she gained experience in reviewing, processing, and managing FDA enforcement actions and supervising FDA staff. Stephanie earned a master’s degree in Biomedical Regulatory Affairs from the University of Washington, a master’s degree in Biochemistry, and a B.S. in Biochemistry and Molecular and Cellular Biology from the University of Arizona.
 
*Not admitted to practice law.