Nora Dowell is our guest on KISC My Health Radio show with Peter Mingils and Stephen Lukawski. Each week, Stephen Lukawski selects people who are truly the Key Influencers and the Super Champions, and this week's guest radio show host was Cran-Tastic!

Nora Dowell shares her unbelievable story about her history as an expert in the Industry, and now she is a Senior Vice president of Quality, Regulatory, and Research and Development

Here is more information about N O R A D O W E L L:
Nora Dowell | CQA, CQMOE, SSGB, FSVP L.I.

Senior Vice President, Quality/Regulatory/R&D
EXECUTIVE SUMMARY
Industry leader driving educational campaign and regulatory update initiatives for Dietary Supplements
members. Over thirty years of successful leadership in the Dietary Supplement and Food industry, with a
passion on product quality/safety, GMP and Regulatory Compliance, continuous improvement and lean
processes, with strong trackrecord of improving all aspects of quality and regulatory affairs in a manufacturing
environment driving quality culture all across the organization. Development and effective implementation of
programs and process improvement initiatives within quality control, quality assurance, regulatory affairs,
operations and logistics departments which resulted to customer satisfaction, customer retention, increased
business share and ultimatelyincrease bottom line. Extensive knowledge of current Good Manufacturing
Practices (cGMP) for Dietary Supplements (21CFR Part 111), cGMP for Human Foods (21 CFR Part 117),
cGMP for Cosmetics (ISO 22716),cGMP for Animal Food (21 CFR Part 507 and 117), cGMP for Drugs and
Finished Pharmaceuticals (21 CFR Parts 210-211), FTC Labeling, CBP Labeling, USDA Import Requirements,
FSMA/FSVP, Health Canada, Therapeutic Goods Administration, and have a working knowledge of other
industry regulations such as: Japan Ministry of Health, Korean FDA, European Union Directive and Latin
America.
ACCOMPLISHMENTS

• Established and implemented quality systems and procedures for a newly founded company, developed
  a skilled quality workforce, constructed analytical and microbiological laboratories, and supported
  operations in the development of the new manufacturing facility.
• Lead the industry in regulatory updates/awareness in collaboration with ASQ and FDA by founding
  SoCal DSC (SoCal Dietary Supplement Consortium), host yearly events and provide speakers from the
  FDA, USDA, FTC, trade organizations, industry expert, etc with participation from over 12 countries.
  Result: Recipient of Leadership award from FDA, Office of Regulatory Affairs
• Trained Certifying Body Auditors (SGS, UL, Eurofins, Intertek) to calibrate auditors and standardize
  facility audits as part of the Supplement Safety Consumer Safety (SSCI) initiative where Nora is part of
  the board and the Benchmarking Committee.
  Results: Increase number of auditors trained in 21 CFR Part 111 and other regulations related to Dietary
  Supplements.
• Developed standard for SSCI which was patterned against GFSI and is used by Certifying Body (CB)
  partners like: UL, SGS, Intertek and Eurofins for SSCI audit and certification.
  Result: SSCI standard developed and is currently used by partner CB's.
• Part of the Technical Working Group in the development and update of SQFI Food Safety Code: Dietary
  Supplement Manufacturing, Edition 10. This is still in progress with implementation date of 2025.
• Participated in the development of standard for NSF/ANSI 455-2: Dietary Supplement GMP
  Certification.
  Result: Standard developed
• Audited Walmart manufacturers against SSCI standard for both local and international including China,
  South Africa, India and Canada.
  Result: Increased qualified suppliers for Walmart and Sam's Club.
• Developed, implemented and maintained quality systems, including Complaint Management, Deviation
  Management, Non-Conformance/CAPA, Change Control, Training and Document Management and
  Control.
  Result: No FDA 483 issued and maintained a scorecard of >90% in Quality as issued by customers
• Reorganized, redesigned and restructure a Quality Department to streamline all activities, processes and
  procedures to increase efficiency and internal customer support. over $700K yearly savings and over
  50% improvement in overall processes.
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  Result: over $800K yearly savings (70M company) and over 50% improvement in overall processes.
• Developed a Quality improvement focus group composed of cross functional team members to identify
  GMP issues and develop a sustainable corrective and preventive action plan.
  Result: Within first year reduced non-conformances by 59%, reduced customer complaints 54%, and
  reduced third-party audit observations by 78%
• Trained logistics employees on 5S and conducted a kaizen event in warehouse organization
  Result: Improve delivery efficiency of component supply to manufacturing and packaging by 40%,
  increased warehouse space availability by 30%, and reduced waste due to spillage and contamination by
  20%
• Led the Material Review Board (MRB) to identify/evaluate potential salvage of products or raw
  materials. Result: $1.2M savings for an $800M company
• Overhaul the Quality Control department, optimize laboratory procedures, streamline all testing
  needs, cross train employees, updated specifications and acquire rapid instrumentation.
  Results: Cost savings from outside testing fees of over 500K (80% saving)
• Consolidated supplies and work with vendors to avail of volume, rebate and other type of discounts to
  reduce departmental expense.
  Results: over $300K yearly savings
• Acquired certifications for the company to be in a position of competitive advantage once new products
  from the customers requiring certifications are out for bid.
  Result: Increased portfolio for Walmart by over $20M yearly and Walgreen by over $2M yearly
• Developed a comprehensive "Supplier Qualification Program” including supplier audit local and
  overseas.
  Result: Increase supplier reliability and improve release reliability by 20%
• Act as a liaison for the company to Walmart, Sam's Club and Walgreen and part of the new business
  developmental team to work on new product development and launches.
  Result: Award of new business of up to $30M yearly.
• Conducted supplier audit in China, India, Philippines, Europe and develop business continuity plan
  with the suppliers.Result: No disruption on raw material supplies resulting to on time delivery of
  products to the customers.
• Reduced outsourced testing by optimizing inhouse testing laboratories to reduce TAT (turn- around
  time) and reduce testing cost.
  Result: Reduced TAT of material use and release of Finished product by 30%
• Developed "XX University Training Program”, to provide professional development for employees in
  process improvement, GMP compliance, Lean Six Sigma Enterprise, Regulatory Compliance, Project
  Management, and Customer Service Satisfaction and Retention.
  Result: A cultural change in the organization toward quality improvement, GMP and regulatory
  awareness resulting to increased overall efficiency, reduce lead time and increase customer satisfaction
• Developed best in class management team and quality/regulatory department including policies and
  programs in alignment with the company strategy.
  Result: Developed leaders to hold management positions from Supervisors to Directors in $B dollar
  companies.
  PROFESSIONAL EXPERIENCE
  January 4 2021 – Present
  President, Nora Dowell Consulting Services
  Laguna Niguel, CA
  Provided the following services to clients:
• Reorganize, redesign and restructure organizations to streamline all activities, processes and procedures
  to increase efficiency, customer satisfaction, bottom line and business growth.
• Virtual Quality department to brand owners and provide regulatory and quality oversite to the comanufacturers and develop procedures to be in compliance with the regulations.
• Support new facility build up by development of the quality systems, procedures, policies and
  collaborate with other stakeholders from onboarding to product launch.
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• Develop/improve SOP's, policies, forms, Master Manufacturing Record, Batch Production Record,
  finished product/raw material specifications and other related documents to improve efficiency and
  increase bottom line.
• Develop Amazon compliance package and assist Amazon suppliers to comply with the current
  compliance guide published in the Seller portal.
• Develop label copy, conduct existing label review and website review to ensure compliance to the
  requirements of FDA, FTC and CBP.
• Develop company's Quality Management System
• Review client's website, marketing and promotional materials, and other related literature for labeling
  compliance.
• Collaborate with the FDA for industry related issues and provide feedback to clients and other industry
  members.
• Provide training in GMP, Quality Systems, Prop 65, Intentional Adulteration, Labeling, FSVP, FSMA,
  Lean Process, etc.to clients.
• Provide training to Certifying Body auditors such as UL, SGS, Eurofins, Intertek and trade organization
  such as CHPA.
• Conduct facility audit, assess gaps in current processes and provide solutions for GMP compliance and
  process improvement to increase productivity, efficiency and bottom line both local and international.
• Assist in the design and development of new manufacturing facilities to ensure regulatory and GMP
  compliance
• Assist in the construction of in-house testing laboratories for clients including acquisition of major
  instruments and price negotiations resulting to substantial price discounts
• Help California clients avail of the state training funding through ETP
• Negotiate pricing with third party testing laboratories and suppliers for lab/facility supplies.
• Negotiated pricing for acquisition of major laboratory instruments such as HPLC, HPTLC, ICPMS,
  Micro Rapid Test Equipment and availed significant discount for the client.
  May 2014- December 2020
  VP, Global Quality and Regulatory Affairs
  International Vitamin CorporationIrvine
  Irvine CA
  March 1998- May 14, 2014
  VP, Quality and Regulatory Affairs
  Adam NutritionMira Loma California
  July 1990- February 1998
  QA/QC Supervisor
  Nion Laboratories, purchased by Weider Nutrition Group
  Irwindale, California
  EDUCATION
  MA, Mathematics, University of Southeastern Philippines, Philippines
  MA, Chemistry, Ateneo De Davao University, Philippines
  BS, Chemical Engineering, University of Mindanao, Philippines
  CERTIFICATIONS
  Preventive Control Qualified Individual (PCQI) – FSPCA
  Foreign Supplier Verification Program (FSVP) Lead Instructor – FSPCA
  Certified Quality Manager for Operational Excellence (CQM/OE) – American Society of Quality (ASQ)
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  Certified Six Sigma Green Belt – American Society of Quality (ASQ)
  Six Black Belt (certificate) – American Society of Quality (ASQ)
  Certified Quality Auditor (CQA) – American Society of Quality (ASQ)
  Project Management
  Dietary Supplement, cGMP
  Hazard Analysis Critical Control Point (HACCP)
  Global Regulatory Affairs Specialist (EU, Latin America, Japan)
  Microscopic Identification of Popular Botanical Materials
  Waste Water Management
  Leadership
  OSHA
  AWARDS
  Leadership Award, 2016 – FDA Office of the Regulatory Affairs
  Leadership Award, 2018 – ASQ, Food Drug and Cosmetics Division (National)
  Leadership, 2015 – ASQ, Section 701, Orange County
  PROFESSIONAL ASSOCIATIONS AND INDUSTRY INVOLVEMENT
  Chair- Southern California Dietary Supplement Consortium
  Board Member- Supplement Safety and Compliance Initiative (SSCI)
  Dietary Supplement Group Leader- American Society for Quality, Food Drug and Cosmetics Division
  Governance Committee member- American Herbal Product Association
  Member – Technical Working Group, SQFI
  Education Chair- American Society of Quality (ASQ), Orange Country
  Member- Orange County Regulatory Affairs (OCRA)
  Industry Speaker- Various industry event, local and national

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