George Gary Calafactor
George Calafactor is a 28-year food, cosmetic, drug, biologic, clinical, and medical device quality assurance and regulatory compliance veteran.
Mr. Calafactor has over 21 years of FDA / governmental experience also as an analyst and level II certified international medical device investigator and over 7 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. George not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, but has also performed various pharmaceutical and medical device quality assurance and regulatory compliance operations, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and EU enforcement policies.
