Workshop Instructor
George Calafactor
George Calafactor is a 30-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 9 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, biologic, 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.
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’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 obtaining online a Master in Pharmaceutical, Biologic, and Medical Device Regulatory Affairs 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.
George Calafactor is a 30-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 9 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, biologic, 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.
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’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 obtaining online a Master in Pharmaceutical, Biologic, and Medical Device Regulatory Affairs 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.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: [email protected]
