OUR TEAM
Mark Hackman
Private Consultant on Food and Drug Administration (FDA) related matters. Primary focus has been working with various start-up companies interested in marketing foods, dietary supplements, medical devices, and most recently Medical Countermeasures for COVID-19. Senior level Regulatory Compliance and Product Stewardship Manager with deep regulatory knowledge from 5 years at British Petroleum (BP) and 18 years at the U.S. Food and Drug Administration. Expertise includes regulatory pathways in biofuels R&D, current Good Manufacturing Practices (cGMP) for pharmaceuticals, (QSR) medical devices, human and animal foods, and veterinary drugs. Successful collaborator with teammates at all levels as well as outside vendors and government officials. Frequently complimented on my ability to explain complex scientific processes in simple terms to teammates and conference attendees.
Many of the details:
Assisted Director as part of the Regulatory team in preparing a Microbial Commercial Activity Notice (MCAN) for two Genetically Modified Microorganisms (GMM) used in biofuels fermentations, resulting in their approval.
Interfaced with Research and Development Teams to collect scientific data needed to support preparation of two MCAN’s four organism over the course of four years.
Developed detailed schematic to educate management about regulatory pathways, from R&D to commercial activities, for company’s biotech development program.
Discovered an exemption to market GMM without need to file a full MCAN, saving the company $500,000 and six months of time.
Participated in weekly conference calls with demonstration plant for continuous manufacturing, risk management, and process improvements for five years.
Worked with R&D, manufacturing, marketing, business development, and salespersons for marketing of firm’s industrial and food enzymes products for two years.
Wrote and/or reviewed 250+ Standard Operating Procedures (SOPs) for receipt, shipment and use of 2000+ biological samples for a new company.
Led training for 100+ BP Biofuels employees in Regulatory Compliance, Good Manufacturing Practices, Risk management, and Global Harmonization for the Classification and Labeling of Chemicals. Movement of Plant and Biological Materials in Interstate Commerce, Toxic Substance and Control Act Regulations and Biosafety.
Developed precedent-setting case, which lead to new regulations and policies for use of human tissue for transplant.
Recognized and awarded for exceptional management of a precedent-setting seizure of imported candy implicated in the death of seven children by asphyxiation.
Advised foreign government officials on inspection programs for FDA-regulated industries in their respective countries once a year over four years; provided technical assistance on the general design and layout of pharmaceutical and medical device manufacturing plants.
Executed the planning and logistics of more than 150 foreign pharmaceuticals, medical devices, low acid canned foods, biological products, and Mammography Quality Assurance Act establishment inspections.
Won the 2013 BP Beacon “Best of the Best” award for exceptional work which allowed US-made bioethanol and biodiesel to be sent to London for 2012 Olympics.
Received more than 25 FDA awards for exemplary service, including two Center Director Awards, FDA Investigator of the Year, and the designation of Charter Member of FDA Hall of Fame.
Holds degree in Biological Sciences, multi-discipline from Cal Poly State University.
Contact information: 858-472-8075 and Mark.Hackman@testprocessoversight.com
