Heather Duncan Fairman

DF Guardian Consulting, Inc.

- Advise companies on organizational and leadership structuring and how to develop qualified and solution-oriented personnel through training, education and creative mind-set approaches, strengthening company efficiencies increasing bottom lines. 
- Guide firms in specific audit practices and areas of concentration related to ensuring foreign and domestic ingredient supplier requirements are met (i.e. FDA, Third-Party Certifications, Self-Audits). Advise and guide both domestic and foreign Ingredient Suppliers and Supplement manufacturers through regulatory interpretation of FSMA (Food Safety Modernization Act) requirements, as well as identify and prioritize the need for critical documentation and testing, training, education and awareness related to these compliance standards. 
- Provide both domestic and foreign companies, with development strategies and support for FSVP (Foreign Supplier Verification Program) offices while managing the need for concurrent company growth. 
- Provide regulatory support and guidance to OTC drug excipient manufacturers concerning development and import of certain animal and biologic ingredients. 
- Develop, establish, review and guide firms with executing thorough systematic SOPs, as well as how to handle FDA and third-party audits, issues, FDA 483 responses and CAPA (Corrective Actions / Preventive Actions) with the intent to adequately meet compliance and avoid Warning Letters. 
- Guide contract suppliers and customers through the development of effective contract partnerships and Quality Agreements that result in mutually sustainable and beneficial outcomes. 
- Provide guidance on how to establish and ensure transparency consistently throughout the supply-chain segmentation (i.e. “farm to fork” concept).

Chief Executive Officer

Maxwell Leadership

Transformational Leadership education and training that prepares industry leaders to be successful in building strong leaders, developing effective teams, navigating critical issues and creating innovative solutions for industry challenges.

Coach, Trainer, Speaker

EAS Consulting Group, LLC

Independent Consultant in US FDA and various foreign country Regulatory Affairs and Quality Management Systems matters for mid-size and large supplement companies.

Independent Consultant

NaturesPlus

Director, Corporate Quality, Compliance, and Regulatory Affairs

Manager, Corporate Quality Assurance

Collaborative Labs, Inc.

Collaborative Labs, Inc., East Setauket, NY

Senior Manager, Quality Assurance/Quality Control,

Quality Assurance Manager,

The Nature's Bounty Co.

Quality Assurance/Quality Compliance/Regulatory Affairs Associate

New York Blood Center

Quality Control Microbiology/Bioassay Supervisor,

Heather is a Skilled Science and Executive professional with over 30 years’ executive leadership and management experience with highly effective results in Regulatory Affairs, QA/QC environments in the Dietary Supplement, Food and Beverage, Supply Chain Segment, Biologics, OTC Pharmaceutical and Cosmetic industries; served in roles as Chief OSHA Safety Officer establishing highly effective corporate safety and security programs. 

She has proven ability to help companies avoid product recalls, FDA 483 violations and Warning Letters, and achieve maximum performance and transformational change as a results-oriented, dynamic motivational leader. Heather is able to analyze and “operationalize” complex and highly technical regulatory and legislative language; uniquely create mutually beneficial contract partnerships; establish thorough procedures and robust quality systems, policies and personnel training that result in cost reductions and improved efficiencies.

Additionally, Heather serves as a Technical Advisor to the UN organization SIDS DOCK IWON (Island Women Open Network), inclusive of the Small Island Developing States (SIDS) where she leverages her expertise to support capacity building and sustainable development. As a certified Maxwell Leadership Coach, Speaker, and Trainer, she is passionate about leadership development, empowering individuals and businesses to achieve their full potential through targeted education and motivational training.

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