Heather Duncan Fairman
About
Heather Duncan Fairman is from Deer Park, New York, United States. Heather Duncan is currently Chief Executive Officer at DF Guardian Consulting, Inc.. In Heather Duncan's previous role as a Director, Corporate Quality, Compliance, and Regulatory Affairs at Natural Organics, Inc.; Natural Organics Laboratories, Inc., Heather Duncan worked in until Jan 2017. Prior to joining Natural Organics, Inc.; Natural Organics Laboratories, Inc., Heather Duncan was a Manager, Corporate Quality Assurance at Natural Organics Laboratories, Inc. and held the position of Manager, Corporate Quality Assurance. Prior to that, Heather Duncan was a Senior Manager, Quality Assurance/Quality Control, at Collaborative Labs, Inc. from Jan 1999 to Jan 2001. Heather Duncan started working as Quality Assurance Manager, at National Nutritional Laboratories, Inc in Jan 1998. From Jan 1997 to Jan 1998, Heather Duncan was Quality Assurance/Quality Compliance/Regulatory Affairs Associate at Nature’s Bounty. Prior to that, Heather Duncan was a Quality Control Microbiology/Bioassay Supervisor, at Melville Biologics/ New York Blood Center from Jan 1989 to Jan 1996.
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Heather Duncan Fairman's current jobs
- 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).