Technical Regulatory Compliance Quality Expert Witness

EXPERIENCE:

since Oct 2009
Compliance Services, Vista, CA Principal Consultant & Founder
A consultancy specializing in technical, quality and regulatory affairs issues for Food companies, especially Dietary Supplement brands and manufacturers and the ingredient companies supplying them.
Providing GMP training and implementation, audits, and Compliance Gap Analysis in the US and Canada. Using more than 30 years of Industry experience and extended education in the area of Regulatory Affairs and Quality Management, to help US-based firms maintain compliance with current regulations, including food safety, labeling, and Good Manufacturing Practices. Actively involved in programs to extend Industry’s understanding of GMPs, state-of-the-art sanitation, production & process controls, formulation for product safety, and other issues that embody the values of responsible Industry Stakeholders.

Sept 2008 to Sept 2009
Indigo Labs, Oceanside, CA  VP, Quality & Regulatory Affairs
A young company specializing in the custom manufacture of liquid dietary supplements. (no longer in business)

Responsible for creating SOPs, all reports, specifications, Master Manufacturing Records, and Production Batch Records. Trained staff on SOPs and created innovative training tools. Developed and implemented Quality systems. Twice successfully filed and received Canadian NHPD manufacturing site approval. Interacted with customers on technical and regulatory issues.

Sept 2000
B&D Nutritional Ingredients, Vista, CA VP, Technical & Regulatory Affairs
A sales & marketing company with long-term representation agreements for branded natural to source vitamin materials, dietary ingredients, and natural-source food additives.

Sept 2008
Provided technical and regulatory information essential for growth in domestic and international markets, supported customers, principals, and those within B&D. Developed and launched line extensions. Helped principals (ADM, Constellation Brands Polyphenolics’ division, Eastman, Vitatene, etc.) develop technical documents and regulatory information for dietary ingredients, food additives, pharmaceutical and cosmetic ingredients. Wrote the company’s first SOPs. Expanded expertise in Regulatory Affairs, including BSE/TSE controls, GM-status issues, requirements under the Bioterrorism Act, and Dietary Supplement GMP details and implementation under DSHEA.) Involved with CRN, representing the company.

Sept 1994 to May 2000
B&C Nutritional Products, Vista, CA Vice President/Controller
A custom manufacturer of dietary supplements (since merged with MeriCal, Inc.)
Managed Accounting, Customer Service, Quality Control, Regulatory Affairs and Human Resources. Customers were both domestic and international. Personally handled the corporation’s largest customer, Trader Joe’s, accounting for +50% of annual sales. Learned and applied DSHEA and other regulations. Audited formulas and composed label copy. Assisted with Unix computer system administration. Authored first inclusive SOPs. Arranged training and certifications for production and quality personnel. Integrally involved with developing the infrastructure and platform for company growth from $1 million to $15+ million. Served on the Board of Directors and acted as Corporate Secretary. Represented the Company at the Council for Responsible Nutrition.

April 1991
Takeda USA, Orangeburg, NY (California office)  Account Manager/Product Manager
The largest Japanese pharmaceutical company and, at the time, the second largest global producer of to ascorbic acid and other essential vitamins as fine chemicals, and an excipients re-seller.

Sept 1994
Direct account responsibility for food, beverage and dietary supplement manufacturers in the Western US, with emphasis on vitamins and fortification products. Served as Product Manager for microcrystalline cellulose, traveling nation-wide with sales and providing technical support 1993-94. Learned NLEA regulations and worked with major food and juice processors, applying technical and regulatory insight to extend contact base and company technical service offerings as a means of account development.

OTHER EXPERIENCE:

1985 Account Manager, Western US Crompton & Knowles, NJ
Sales & tech support: FD&C colors, aqueous-based color application technology and systems for foods, pharmaceuticals, dietary supplements & candy as a response to Air Quality Regulations requirements to phase out solvent-based systems. Flavors.
1984 Director, Materials Management VitaFresh Vitamin Co, CA
Purchasing department head for manufacturer of dietary supplement tablets and capsules. Made Scooby-doo™ & Hello Kitty™ Children’s’ Chewables. First to supply Costco with packets in 30-day cartons. Team implemented progressive packaging technologies for tamper-evidence as a CAPA to resolve consumer concerns. (Company later became part of Leiner Health.)
1980 Technical Sales, Western US FMC – Food & Pharma, PA
Sales & tech support: cellulose-based food additives with innovative applications, including binding, bulking, plating, absorption, disintegration, suspensions, dispersions, film-forming (edible latex.) Technology transfer key to activity.
1977 Technical Sales, Western US Mendell Company, NY
Sales & tech support: value-added ingredients for direct compression manufacturing of pharmaceutical and dietary supplement solid dosage forms. Required long-term technical partnerships to enable technology transfer to rapidly expanding supplement manufacturers and conservative major pharmaceutical companies.

EDUCATION,TRAINING & EXPERIENCE: (partial listing)

• IFPTI/FSPCA, Foreign Supplier Verification Program Training, Sept-2017
• IFPTI/FSPCA, Preventive Controls for Human Food (Qualified Individual (PCQI-HF)), May-2016
• Joy’s Quality Management GMP Refresher, 2013 (Joy Joseph, trainer)
• ASQ Certified Quality Auditor, since June-2013
• ASQ Certified HACCP Auditor, April-2011 – December 2018
• Joy’s Quality Management GMP Refresher, Feb-2011 (Joy Joseph, trainer)
• “Better Process Control,” Chapman College, Aug-2009
• Center for Professional Advancement, Dietary Supplement GMPs Training, Mar-2008
• University of Maryland, Baltimore (Industrial Pharmacy – coursework), Jan-1983
• University of California, Riverside (BA), 1975
• Speaker & attendee: ACI/CRN Legal, Regulatory & Compliance Forum on Dietary Supplements, Jun-2015
• CRN/NPI-Virgo webinar: Class Action Lawsuits, Jun-2015
• Spherix/JQMS: Food & Dietary Supplement Hot Topics Forum, Mar-2015
• AHPA Botanical Congress: Tools & Methods for Botanical Identification, Oct-2014
• FIBR Annual Update on County, State & Federal regulations, Apr-2013
• Presenter & attendee: CRN/NPI-Virgo webinar: Dietary Supplement GMPs, Feb-2012
• Dept of Commerce/NHPD Webinar on Canadian Natural Health Product Filings, Jul-2012
• ASQ/FDC FDA Annual Conferences 2004 through 2014
• HACCP, Food Safety/FIBR Training Institute, Spring – 2010
• CAPA Workshop, Orange County Regulatory Affairs, Mar-2010
• Workshop on Filings, Natural Health Products Directorate (Health Canada), Dec-2009
• Near InfraRed Instrument Operation & Applications, ASD, Boulder, CO, Apr-2009
• Conference on Adverse Event Reporting, CHPA/CRN, Jun-2007
• Phytochemicals: Aging & Health, Nutrilite Health Institute & Cal Poly Pomona, Oct – 2006
• Glatt Fluid Bed Technology Workshop, Nov-2006
• Fine Particle & Nanoparticle Processing, University of Wisconsin, Jan-2004
• Food Powder Technology & Utilization, IFT Continuing Education, Jun-2002
• Emulsions & Suspensions, FMC Corporate Training Center, Princeton, NJ, Mar-1983
• Direct Compression Technology Workshop Series, SME, 1980

SKILLS & COMPETENCIES:

• Dietary Supplement labeling
• QA-QC white papers
• Technical marketing pieces
• Structure/Function Claims substantiation
• 483 Remediation
• Procedures (SOPs)
• GMP (21 CFR §111, §114, §117, §120 )
• GMP auditing, implementation

Specifications, Certificates of Analysis

Gap analysis (relative to standards and/or SOPs)
Allergen Control Programs
Facility Layout & Process Flow ideation
Interaction with Process Engineering for GMP
Food Safety Plan assistance
Quality Management Plan assistance
Expert Witness

Training: 111 Dietary Supplement GMPs; §117 Food GMPs; §117 Supply Chain Requirements

Regulatory Specialties Under FDA: Food Drug & Cosmetic Act (particularly as amended by NLEA,
DSHEA, FQPA, FALCPA and FSMA.)
The Dietary Supplement & Non-Prescription Drug Consumer Protection Act (includes Serious Adverse Event Reporting)
21 CFR 111 Good Manufacturing Practice for Dietary Supplements 21 CFR 117 Food GMPs & Preventive Controls for Human Food
Under EPA: FIFRA, process wastewater
Under FTC: Dietary Supplement Advertising & Claims
Under OSHA: Lockout/Tagout/Blockout, Safety Data Sheets “Right-to-Know”
California Regulations: Sherman Act, OEHHA (for “Prop 65.”)

Languages Accounting Computer

• English, French, some Spanish
• General Ledger, cost accounting, asset management
• Microsoft Word, Excel, PowerPoint, Access; Adobe Acrobat; Sage MAS 90, MACOLA, MAS 500, ACT

INDUSTRY ACTIVITY:

• American Society for Quality (ASQ), member since 2011
• Certified HACCP Auditor (since 2011); Certified Quality Auditor (since 2013)
• Council for Responsible Nutrition (CRN), associate member since 2011
• CRN Regulatory Affairs Committee, 5 years for B&D Nutritional Ingredients & since 2011
• SIDI Working Group (joint task force of CRN, NPA, AHPA, CHPA).
• As B&D’s representative, focused on a format for presenting essential “Standardized Information on Dietary
• Ingredients” and food additives in a way that supports Dietary Supplement GMP compliance needs
• Represented the industry initiative: co-presented SIDI highlights and benefits at IFT Expo 2007 (Chicago) and solo at
• SupplySide West 2007 (Las Vegas)
• Drug, Chemical & Allied Trades – West (DCAT) (past)
• General Chair, Annual Meeting, 1984
• Business Program Chairman, four Annual Meetings, 1982 – 2007
• AOAC International, past member
• Institute of Food Technologists, member