George Gary Calafactor is a 28-year food, cosmetic, drug, biologic, clinical, and medical device quality assurance and regulatory compliance veteran. He has over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and extensive 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 experience with all types of US and foreign regulated facility audit and inspection, 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, and more.
George’s expertise is primarily in medical device quality assurance and regulatory compliance, and has vast knowledge utilizing US, European, Canadian, Australian, Brazilian, Japanese, and Chinese medical device quality system and clinical laws, regulations, standards, and guidelines.
George has 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame and an MBA in International Business from Indiana University. Currently, George is obtaining online a PhD in International Business from Walden University. George has vast internal working knowledge of medical device regulatory compliance and quality assurance operations, but also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems.