ABOUT

With my 30+ Years Experience in the U.S. Food and Drug Administration,

I can help your firm understand FDA's regulatory requirements and the

compliance actions and processes that can affect your operations,

as well as, address any inspectional issues you may have.

EXPERIENCE

Current FDA Law Instructor to the Agency compliance officers, mission support, headquarters personnel, and the Center for Veterinary Medicine.
Director of the Denver District Office Compliance Branch
Compliance Officer
Supervisory Investigator
Resident-in-Charge
Field Investigator
International travel to perform audits, data reviews, corrective action verification, and training, including India, China, and Mexico

For a more in-depth review of my FDA experience, please see below.

14 years as the Director of the Compliance Branch (DCB) in the Denver District Office (DEN-DO).

Supervisor to five compliance officers, a recall coordinator, Legal Administrative Specialist (Freedom of Information specialist), and two Consumer Safety Technicians.
Reviewed evidence collected from the Investigations and Laboratory Branches to formulate informal and legal strategies to bring non-compliant firms into lasting compliance.
Conducted final reviews of draft legal documents and documentation submitted to the Office of Compliance for the Centers, the Office of Enforcement and Import Operations, FDA’s Office of the Chief Counsel, and the U. S. Department of Justice for consideration for regulatory action.
Guided and coordinated regulatory activities related to untitled letters, regulatory meetings, warning letters, seizures, injunctions, civil money penalties, and criminal prosecutions.
Coordinated casework with state and local counterparts, and other federal agencies including DEA, FBI, and USDA.
Participated in Regulatory Meetings with regulated industry to discuss the state of compliance of their firms and the path forward to comply with the regulations.
Trained and served as Planning Section Chief for the Incident Management Team for the Southwest Region.
Served as the Chair of the Directors of Compliance Branch Advisory Committee and addressed issues that involved and impacted national policy, procedures, and practices related to compliance branches.
Participated on committees that involved the implementation of the suspension of registration, inspection of food records, and administrative detention of foods provisions of the Food Safety Modernization Act (FSMA).
Successfully submitted a recommendation for using the mandatory recall authority under FSMA that recalled pet treats contaminated with salmonella, to use this authority.
Provided guidance that successfully submitted an order for Suspension of Registration that controlled the nation’s largest manufacturer of organic peanut and nut butter products in which salmonella was found, again setting precedent by becoming the first district in the nation to exercise this new authority.
Developed a strategy, background paper, and forms/templates for regulation of medical devices in the Latin American countries of the Pan American Health Organization (PAHO) as part of the World Health Organization of the FDA Leadership Program. The data and summaries detail were used in subsequent PAHO publications.
Six years of experience as a Compliance Officer including participation on the Medical Device Team in the Minneapolis District Office. Responsible for the branch’s activities in the health fraud area
Experience as a compliance officer in the areas of drugs and biologics.

TRAINING, DEVELOPMENT AND INSTRUCTION

Served as an instructor, curriculum developer, CAG (Course Advisory Group) member, and expert panel member for the FDA’s New Hire Law Training Course, Food and Drug Law II (Compliance Law), Practical Compliance Applications, "Introduction to FDA Fundamentals for ORA Mission Support Professionals, and Food and Drug Law for Administrative and Support Staff at the Center for Veterinary Medicine. I Continue to participate in the Compliance Law, Compliance Applications, and Mission Support training courses as explained below:

The New Hires Law course is the FDA’s required basic law course. It is a required course that presents the legal bases for determining that regulated products are adulterated or misbranded, prohibited acts, penalties, regulatory actions, legal processes, and elements of proof. Precedent cases, court structure, and case law are presented.

The Compliance Law course presents information similar to that presented in the New Hires Law course to more experienced compliance officers, supervisory investigations, laboratory management, and headquarters personnel. The course serves as both a refresher on the law and a forum for discussing policy and real-life cases that continue to impact new laws and FDA’s interpretation of them.
As an instructor and CAG member for Division of Human Resources Development (DHRD’s Practical Compliance Applications Course, I helped to redesign the curriculum to reflect current procedures, policies and law. I am currently on the Instructors Cadre for the course. This course is a “how to” practical guide on how to process seizure and injunction actions including important evidence and issues in the recommendation; the process for bringing the cases to the headquarters units and ultimately to court; and drafting the involved legal documents.
The courses for mission support professionals covers the process for implementing new regulations under the Administrative Procedures Act, the history of FDA law, regulations, guidance, current policy, new drug approval process, medical device approval process, prohibited acts, penalties, and regulatory options.
In past years, I presented the regulations and policies relating to Medicinal Gases for FDA’s Drug Manufacturing Course to investigators nationwide.

DETAILS

Acting Director in the Office of Executive Operations
Acting Director of International Travel Operations Branch
Acting District Director in the Minneapolis District Office
Acting Director of the Investigations Branch in the Minneapolis District Office
Acting Director of Compliance Branch in the San Francisco District Office
Acting Compliance Officer in the Center for Biologics Evaluation and Research
Acting Case Reviewer in the Division of Compliance Management and Operations

EDUCATION AND BROAD EXPERIENCE

Bachelor of Arts in Organismic Biology from the University of Colorado, Boulder, CO, 1973
Bachelor of Science in Medical Technology from the University of Colorado, Denver Medical Center, 1980
Certification for Secondary Education Teaching (Science) from the University of Colorado, 1975
Certified/registered as a Medical Technologist and a Histologic Technician with the American Society of Clinical Pathologists (MT, HT, ASCP)
Graduate of the FDA (U.S. Food & Drug Administration) Leadership Development Program 2000-2001.
Previous work experience includes:
- Laboratory assistant in research involving intermediary metabolism;
- Created/tested laboratory exercises for a college level (Purdue University), audio tutorial format biology curriculum (Biological Sciences Curriculum Study);
- Taught high school science and math for two years;
- Assisted in autopsies as a diener (removing organs during autopsy) for six years; and
- Worked as a histologic technician for three years.