- Regulatory support for organizations dealing with new product approvals and introduction, expanding operations, technology transfer, and changing customer, regulatory or certification requirements.
- FSMA (Food Safety Modernization Act) compliance in regulatory analysis, strategies and meeting deadlines.
- FSPCA Lead Instructor (Human Foods Certified and Animal Foods Certified), providing PCQI training to industry and regulatory agencies, including FDA.
- Preventive Controls Qualified Individual (PCQI): Training for both human and animal food.
- FSPCA (Food Safety Preventive Controls Alliance) Certified -Lead Instructor - Trainer. Leading companies in their entire food safety teams to customized solutions for their particular culture and needs in:
- Design of facility's Food Safety Plan under the new GMP & Risk Based Preventive Controls rules;
- Evaluating existing documentation & compliance systems to utilize where appropriate; revising and preparing new documentation as necessary for the new rules,
- Guidance on the new approach to hazard analysis that requires determination of preventive controls,
- Preparation of the particular preventive controls needed (from Process to Allergen to Sanitation to Supply Chain).
- Guidance with validation of process controls and verification of all controls,
- Preparation of the recall plan required for hazards requiring a preventive control.
Microbiologist and Regulatory Expert
- FDA/EPA site and product approvals for food, feed, and industrial enzymes, specialty chemicals and additives from fermentation, including GRAS notices, AAFCO definitions, cGMPs, HACCP, FSMA, EPA TSCA (MCANs/Tier I & II exemptions), and compliance with NIH guidelines.
- Over 35 years' technical management experience, on site for fermentation and specialty chemicals manufacturing.
- Leveraging commonalities of compliance activities, operating permits, product approvals, certificates with system design and program documentation.
- Providing training to ensure site compliance in markets regulated by FDA (pharmaceutical, food, feed, and dietary supplements); EPA (FIFRA and TSCA, including MCAN and Tier I and II exemptions for microorganisms); NIH GLSP; DEA and ATF.
- Focused industries: Primarily serving the fermentation food, deed and industrial markets in Regulatory Affairs and Quality Systems (RA/QA), directing and managing personnel in health, safety and environmental, QA, QC, Culture and Process Control Laboratories, and site environmental staff.
- Focused areas: Food safety, GMPs, HACCP, Kosher, Halal, microbiology, quality management systems, ISO, ICH, CAPA, site regulatory (FDA, TSCA, RCRA, CERCLA, EPCRA, OSHA), Health Assurance Committee, Institutional BioSafety Committee (NIH Guidelines), fermentation Industry, enzyme manufacturing, documentation, training, auditing, TSCA microbiology-related filings (MCAN, tier exemptions).
- Communication with regulatory officials, other third party organizations, customers, suppliers, and operations personnel to effectively determine compliance requirements, implement, and maintain compliance.
- Coordinated among sites in commercialization of products, harmonization of systems, and development of procedures and laboratory methodology.
- Development of management systems, leading cross-functional teams, and handling of audits in FDA-regulated companies, primarily food, but also some API manufacturing, in both corporate office and on manufacturing site.
Independent Consultant, Present
- Provide technical consulting in the following industry areas: Food safety, GMPs, HACCP, Kosher, Halal, microbiology, quality management systems, ISO, ICH, CAPA, site regulatory (FDA, TSCA, RCRA, CERCLA, EPCRA, OSHA), Health Assurance Committee, Institutional BioSafety Committee (NIH Guidelines), fermentation Industry, enzyme manufacturing, documentation, training, auditing, TSCA microbiology-related filings (MCAN, tier exemptions).
Undisclosed Company, 2004 - Present
Site Director of Quality and Senior Quality Specialist
- Responsible for site quality assurance, including specifications, release and CGMP compliance, customer audits, third party certifications; products included dietary supplements, food and feed, and starting materials for APIs., and responsible for quality assurance of development, qualification, validation, and commercial runs of an API process at CMO sites.
- Recruited, hired and trained additional site QA/QC/HSE Staff.
- Oversaw preparation of construction and operating permits.
- Oversaw and prepared needed documentation for GMP compliance of new construction.
- Handled tech transfer of batch records and other process documentation, and revised all site system documentation to reflect, maintaining an ISO based quality manual.
- Oversaw equipment and process qualifications, obtained kosher and halal approval for additional products.
- Handled all site audits (FDA, AIB, all customers, all Kosher and Halal audits and product and raw material approvals, including special requirements),
- Revised quality systems to comply with ISO 22000.
- Evaluated applicability of dietary supplement GMPs and developed and implemented appropriate procedures to comply.
- Determined certification options for animal feed, integrated additional appropriate compliance requirements, and obtained feed material certification (FEMAS) and later made changes for FAMI-QS.
- Handled similar projects as Senior Quality Assurance Specialist.
Fermpro Manufacturing, LP, Kingstree, SC, Vice President Regulatory and Legal Affairs, 1994 - 2003
- Responsible for QA/QC and HSE in operations including contract manufacturing for clinical supplies and starting materials for API's.
- As business owner and corporate officer, responsible for legal contracts and compliance and for determination of market and material-related site requirements and compliance (including EPA-TSCA, EPA-FIFRA, ATF, DEA, NIH-GLSP) for over 50 contract customers.
- Coordinated quality and regulatory aspects of process transfer for toll (contract) products.
IBIS Limited Partnership, Kingstree, SC, Vice Pres.-Regulatory and Laboratory Affairs, 1991 - 1993
- Responsible for QA/QC and HSE compliance for various microbial products and markets, including food, feed, and industrial.
International Biosynthetics, Charlotte, NC, 1988 - 1991
Director Quality Services and Associate Director Government and Industry Affairs
- Introduced and led Total Quality Management Program from U.S. corporate office, including pioneering in ISO 9000 registration and implementation of Deming Management principles.
- Honored by being selected as seminar assistant and personal aide to a renowned expert and the 4-day seminars.
- Developed programs for compliance related to new rulemaking including EPA, FDA, Canadian WHMIS.
- Provided results of inter-laboratory studies to FCC and AOAC to accomplish publication of official methods for enzymes.
Gist Brocades USA, Kingstree, SC, Director Quality Assurance, 1978 - 1991
- Developed quality assurance system for site produced and products imported from European sister sites. Prepared and led Kingstree site to initial food safety certification (ASI).
Chief Microbiologist, 1978 - 1982
- Led international group of company sites in harmonization of intercompany methods for microbiological and enzyme analysis to meet needs of U.S. market
- Pioneered in ISO 9000 certification.
- Designed an integrated quality and environmental management system for flexibility of a lean enterprise.
- Determined need for and developed programs, continuously improving and integrating new and updated quality, environmental, safety and other site related permitting requirements (RCRA, CAA, SWPPP, OSHA PSM, ATF, DEA, NIH), third party certifications (including AIB and FEMAS, system upgrades for ISO 9000 and ISO 22000), food safety/quality and market-related regulatory (FDA, USDA, TSCA, FIFRA, DEA) and customer requirements.
- Utilized leadership skills to build effective, engaged and involved cross-functional teams. Ensured satisfaction of customers, third party certifying agencies, regulatory agencies, Kosher agencies, and Halal organizations.
- Systems and procedures were benchmarked and indicated as "best practices" by auditors.
Honors & Publications
- Registered Microbiologist (National Registry of Certified Microbiologists, American College of Microbiology): Food, Dairy, and Sanitation Microbiology and Pathogenic Microbiology.
- Certified Instructor: FSPCA-Food Safety Preventive Controls Alliance
Academic and Professional Affiliations
- American Society for Microbiology
- Society for Industrial Microbiology and Biotechnology
- National Registry of Certified Microbiologists
- International Association for Food Protection
- American Society for Quality
- Ambassador for Economic Development, presented by the Governor of South Carolina
- Author of several publications, (peer reviewed journals) and presentations.
- B.S. Microbiology (High Honors), Clemson University, Clemson, SC