HOWARD E. MANRESA
EXPERIENCE IN THE U.S. FOOD AND DRUG ADMINISTRATION:
I have over 30 years of experience with the FDA. Please see my website (ManresaFDAConsulting.com) for information regarding my consulting business.
As the Director of the Compliance Branch (DCB) in the Denver District Office (DEN-DO) of the U.S. Food & Drug Administration, I supervised 5 compliance officers, a recall coordinator, Legal Administrative Specialist (Freedom of Information specialist), and 2 Consumer Safety Technicians in reviewing evidence collected from the Investigations and Laboratory Branches to formulate informal and legal strategies for bringing non-compliant firms into lasting compliance.
Responsible for the final review 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 our 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.
Graduate of the FDA (U.S. Food & Drug Administration) Leadership Development Program 2000-2001.
Served as the Director of the Compliance Branch in the Denver District Office from 2000 to 2014, having performed as a Consumer Safety Officer, Resident-In-Charge, Supervisory Investigator, and Compliance Officer as follows:
• Investigator, Los Angeles District Office 1983-1986
• Resident-In-Charge, Fargo Resident Post (Fargo, North Dakota) 1986-1989
• Supervisory Investigator, Minneapolis District Office 1989-1995
• Compliance Officer, Minneapolis District Office 1995-2000
• Director, Compliance Branch, Denver District Office 2000-2014
Served as the Chair of the DCB Advisory Committee from 2011-2014, addressing issues that involve and impact national policy, procedures, and practices related to compliance branches.
Served as the compliance officer on the Medical Device Team in the Minneapolis District Office. Was responsible for the branch’s activities in the health fraud area and was the backup compliance officer in the areas of drugs and biologics.
During my detail to the Pan American Health Organization (PAHO) of the World Health Organization as part of the FDA Leadership Program in 1999-2000, I developed a strategy, background paper, and forms/templates for regulation of medical devices in the Latin American countries. The data and summaries that I developed during this detail were used in subsequent PAHO publications.
Over the years with FDA, I have had 30 day details as Acting Director of International Travel Operations Branch, Acting Compliance Officer in the Center for Biologics Evaluation and Research, Acting Case Reviewer in the Division of Compliance Management and Operations, Acting Director of the Investigations Branch in the Minneapolis District Office, Acting Director of Compliance Branch in the San Francisco District Office, Acting Director in the Office of Executive Operations, and Acting District Director in the Minneapolis District Office.
Participated on committees that are involved in the implementation of the suspension of registration, inspection of food records, and administrative detention of foods provisions of the Food Safety Modernization Act (FSMA) of 2011. Under my guidance in 2012-2013, DEN-DO successfully submitted a recommendation for using the mandatory recall authority under FSMA to recall pet treats that were contaminated with salmonella. The use of the FDA Mandatory Recall provisions of the FSMA was approved, becoming the first time a district used this authority.
Additionally in 2012-2013, Denver District successfully submitted an order for Suspension of Registration to control a firm and peanut products in which salmonella was found, again becoming the first district in the nation to exercise this new authority.
FDA INSTRUCTOR:
Currently serve 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, Practical Compliance Applications, and the "Introduction to FDA Fundamentals for ORA Mission Support Professionals".
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. Am 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 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.
The course 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.
Presented the regulations and policies relating to Medicinal Gases for FDA’s Drug Manufacturing Course to investigators nationwide.
EDUCATIONAL BACKGROUND:
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)
PREVIOUS WORK EXPERIENCE BEFORE COMING TO THE AGENCY.
Worked as a 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 was employed as a histologic technician for three years.
Howard Manresa, Principal and Co-Owner
Manresa FDA Consulting, LLC
12650 W. 64th Ave., Unit E, #108
Arvada, CO 80004
mobile phone : 720-505-0079
office phone : 720-505-1218
email: ManresaFDAConsulting@gmail.com
website: ManresaFDAConsulting.com