I am ORA Profile: Jane Kreis
Jane Kreis, Import Program Training Officer, Office of Import Operations
I am U.S. Public Health Service Commissioned Corps Captain Jane Kreis, a program training officer in the Office of Import Operations (OIO). I provide training that equips our field-based imports teams with the knowledge and skills needed to carry out their duties of preventing unsafe, harmful, or counterfeit FDA-regulated products at entry ports from reaching American consumers.
Early Career and Developing Highly Trained Teams
I began my career as a clinical pharmacist for the Indian Health Service. I then became an instructor and was certified to administer various trainings, including Basic Life Support—which I still maintain. In 2002, I became a counter terrorism hire in FDA’s Seattle District, where I conducted food, import, pharmaceutical, and bioresearch monitoring inspections. The insights I gained as an inspector prepared me for the role I assumed in 2022, when I became the Office of Import Operations Program Training Officer, supporting Foreign Supplier Verification (FSVP) inspections. FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.
As a training officer, I develop, revise, and facilitate training for FDA-mission support staff to be proficient in their jobs. I provide employee development, planning, and evaluation, as well as problem-solving to support FDA operations, including investigational and compliance activities.
In addition, I train our staff to respond to naturally emerging public health threats, as well as those of a dark and deliberate nature—as our emergency preparedness proves vital to the American people we serve.
Mission-Focused Partnerships
In April 2022, the FDA and Guam’s Department of Public Health and Social Services, its Division of Environmental Health, and its Customs and Quarantine Agency, entered a partnership to enhance collaborative efforts between the agencies to combat fraud and health care abuse and strengthen the security of supply chains. Our shared goals include improving intelligence on imported goods entering the Pacific Region; providing enhanced support and engagement of FDA’s regulatory, laboratory, and criminal investigations capacity and capability in the Pacific Region; and broadening the agency’s overall international presence. Since June 2022, the FDA has maintained a continuous presence in Guam through detail teams.
I assist with these efforts along with emergency response in Guam. As the imports program training officer and a member of the Surgeon General Education Team, for instance, I provided Naloxone training to over 70 Guam-based health, environmental health, and behavioral health staff.
A Storm-Sized Response
In May 2023, Category-5 Super Typhoon Mawar impacted Guam, affecting FDA’s imports team stationed on the island. In response, the FDA immediately established an Incident Management Team to secure the safety of staff and ensure continuity of operations with our Guam partners and other U.S. federal partners.
The storm unleashed numerous challenges, including operations and communications disruptions, staffing and logistics difficulties, and strained resources, to name a few. I served as the virtual Operations Chief and managed several mission-related operations.
Fortunately, the FDA, together with its partners, was able to secure the national supply chain, test and ensure safe drinking water for local citizens, transport and deliver crucial blood supply shipments, prevent the importation of contaminated goods, and provide guidance to the public and industries on food safety, health fraud, and best practices for storing temperature-dependent drug products.
The typhoon, while challenging, underscores FDA’s commitment to protecting public health and effectively collaborating with partner agencies, despite whatever circumstances strike—including natural disasters.
Enjoying My Job
I enjoy training and educating FDA staff and stakeholders about how the Office of Regulatory Affairs ensures the safety, efficacy, and security of FDA-regulated products.
My job allows me to train others to ensure imports from abroad are safe and meet the same requirements as if they were produced domestically.
I am Captain Jane Kreis, an FDA trainer and mission supporter, and #IAmORA.