Mr.George Gary Calafactor

George Gary Calafactor is a 31-year food, cosmetic, drug, biologic, clinical, and medical device quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 10 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’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 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 food, pharmaceutical, biological, medical device, and combination product quality assurance and regulatory compliance operations, such as reconciling FDA Warning Letter and Consent Decree findings, monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, 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, informing management and staff of current FDA and international enforcement policies, assisting start-up medical device/ combination product companies, and facilitating backroom operations during FDA inspections.    George’s educational background includes 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 currently working toward a MS in regulatory affairs in pharmaceuticals, biologics, and medical devices (regulatory compliance concentration) from Northeastern University.  As such, not only does George have vast internal working knowledge of medical device regulatory compliance and quality assurance operations, but he 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.