Expert Profile
George ***** is a 27-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 6 years o ***** as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor.
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 PhD in International Business from Walden University. As such, not only does George have vast internal working knowledge of FDA 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 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.
George’s expertise is primarily in medical device quality assurance and regulatory compliance, and has vast knowledge utilizing US, European, Canadian, Brazilian, Japanese, and Chinese medical device quality system and clinical laws, regulations, standards, and guidelines. However, he is also familiar with and knows the similarities and differences between US food, human and animal pharmaceutical, cosmetic, biologic, tissue, and clinical laws, regulations, guidelines, and operations as well.
George is a self-starter with good written and oral communications skills and has a strong history and a proven track record of leading or working with teams. George strives for continuous improvement, consistency in quality assurance and regulatory compliance with reduced waste while auditing, consulting, and contracting medical device, biologic, and pharmaceutical facilities. George has participated in multiple projects to problem solve and has participated in and/or set up quality audit teams and wrote team reports while in the governmental and industrial capacities. In all projects, George has demonstrated hands on expertise. These skills have resulted in increased quality and operating integrity.
In addition, George is not the typical regulatory compliance and quality assurance expert. Not only does George understand the inner workings of the FDA and regulated industry, but also international management operations. George’s Myers-Briggs profile is also non-typical as well (i. e. ENFP). These additional strengths have given George the necessary skills to multi-task, work as a team player, and be a leader, coach, and mentor while understanding the mechanisms of quality systems and the subsystem linkages balanced with the internal and external business constraints of clients.
Therefore, for over 27 years, George has successfully assisted numerous US and foreign companies to achieve quality and regulatory compliance, especially in the medical device arena.
July 2011- Present Pan America Hyperbarics, Inc. (PAHI), Richardson, TX and Kaohsiung, Taiwan (CHINA)
CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT
• Supplies various medical device quality assurance and regulatory compliance guidance and assistance when requested.
March 2012 Electrika, Inc., Islip Terrance, NY & Somatics, LLC, Lake Bluff, IL
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Assisted with the correction to FDA 483 observations of the specification developer.
• Conducted gap analysis of quality system of contract manufacturer using FDA laws and regulations.
• Assisted with the improvement quality control procedures and SOPs as required.
• Provided regulatory, quality, and technical expertise to the top management.
• Conducted desk audit of the quality system of the contract manufacturer.
• Prepared written audit correction plan.
• Performed various audit correction activities, including revising written instructions, revamping the management control, document and change control, quality auditing, purchasing control, CAPA, and production and process control operations.
July 2010 – May 2012 Biomet, Inc., Warsaw, IN
REGULATORY COMPLIANCE SPECIALIST
• Conducts mock/internal/external FDA QSR, product, and process audits and investigations of domestic manufacturing facilities of Biomet, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, and tissue realms.
• Completes quality records and/or prepares written procedures (such as pertaining to design control, servicing, and document and change control written procedures and CAPA reports) when needed or requested.
• Performs various regulatory compliance activities (such as ‘hands-on’ document and change control administrative activities, FDA product listing activities, and transfer plan reconciliations).
• Heads or assists with various regulatory compliance and quality projects (such as improving the design control, document and change control and internal audit programs).
• Evaluates product designs and manufacturing processes for compliance with regulations.
• Performs onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement.
• Establishes continuous process improvement at various levels at the organization (such as reconciling product registration, listing, and submission data and preparing various quality and regulatory training presentations).
• Extensive background in the enforcement of consumer protection regulations.
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act.
• Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits.
• Knowledge of Medical Device Directives, ISO *****:2003, Canadian Medical Device Regulations, Japanese Medical Device Regulations, Brazilian Medical Device Regulations, and Chinese Medical Device Regulations.
• Ensures that manufacturers’ employees have proper knowledge of applicable regulations.
• Develops and implements business practices improving and reducing operating expenses of company sites (such as supplying solutions to correct any internal and external quality system deviations and preparing various quality system training presentations for future training sessions).
• Collaborates with site manufacturing personnel to gather information and explain findings.
• Advises firm officials on current FDA & EU enforcement policies.
• Conducts informal training sessions on quality, medical device regulations, FD&C law, inspection and investigation techniques and other related topics.
• Communicates with and maintains customer relations with facility personnel (such as during internal audits of other site locations).
• Significant experience in making group presentations to firm officials and personnel.
June 2010 ADB Consulting & CRO, Inc., Pembroke Pines, FL
CONTRACT MEDICAL DEVICE QUALITY SYSTEMS EXPERT
• Provides technical consulting to corporate, legal and government clients.
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant.
Medical Device Client: Confidential, GLP Laboratory, USA
June 2010
• Conducts gap analysis and initial qualification of GLP facility for USA Sponsor-Monitor of IDE medical device using FDA laws and regulations.
• Provides regulatory and compliance expertise to top management and quality departments.
February 2010- May 2010 Pan America Hyperbarics, Inc., Kaohsiung, Taiwan (CHINA)
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Conducted gap analysis of quality system using FDA laws and regulations.
• Assisted with the development of quality control procedures and SOPs as required.
• Provided regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments.
• Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.
• Conducted internal audits of the quality system.
• Prepared written audit correction plan.
• Performed various audit correction activities, including revising written instructions, revamping the document and change control, purchasing control, CAPA, and production and process control operations.
March 2009- January 2010 The FDA Group, Worchester, MA
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Provided technical consulting to corporate, legal and government clients.
• Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
Device Manufacturer: Thermo Fisher Scientific, Middletown, MA
March 2010
• Provided guidance of off label requirements using FDA laws and regulations.
Device Manufacturer: Pan America Hyperbarics, Inc., Kaohsiung, Taiwan (CHINA)
January 2010
• Conducted gap analysis of quality system using FDA laws and regulations.
• Assists with the development of quality control procedures and SOPs as required.
• Provided regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments.
• Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.
• Conducted internal audits of the quality system.
Initial Importer/ Distributor and Contract Medical Device Manufacturer (Installer and Servicer):
Pan America Hyperbarics, Inc. Richardson, TX
December 2009
• Conducted gap analysis of quality system using FDA laws and regulations.
• Assisted with the development of quality control procedures and SOPs as required.
• Provided regulatory, quality, technical expertise to top management and quality, installation, servicing departments.
• Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality and installation/ servicing departments.
• Conducted internal audits of the quality system.
Pharmaceutical, Biologic, and Medical Device Specification Developer: Healthpoint, Ltd., Fort Worth, TX
May 2009
• Conducted gap analysis of quality system written procedures using FDA and EU laws, standards, and regulations.
December 2009 Orchid Design, Shelton, CT
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Provided technical consulting to corporate, legal and government clients.
• Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
Medical Device Client: Mini-Lap Technologies, Inc. Dobbs Ferry, NY
December 2009
• Conducted gap analysis of quality system written procedures using FDA and EU laws, standards, and regulations.
November 2009 Gerson Lehrman Group, New York, NY
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Provided technical consulting to corporate, legal and government clients.
• Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
Medical Device Client: Miura Global Management, LLC, New York, NY
November 2009
• Analyzed business, legal, quality, sterilization and non-conformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.
May 2009- August 2009 Engineering Resource Group, Morris Plains, NJ
CONTRACT MEDICAL DEVICE QUALITY EXPERT/ QUALITY CONSULTANT
• Provides various quality compliance consulting and contracting to corporate, clients.
Contract Medical Device Manufacturer: Medin, Corp, Passaic, NJ
May 2009- August 2009
• Conducted gap analysis of quality system using FDA and EU laws, standards, and regulations.
• Assisted with the development of quality control procedures and SOPs as required.
• Ensured product development follows appropriate design control requirements.
• Provided regulatory, quality, and technical expertise to the engineering, quality, and production departments.
• Conducted training sessions related to regulatory, compliance, quality, and auditing for top management, and to the engineering, quality, and production departments.
• Conducted internal audits of the quality system.
• Developed various regulatory, quality and compliance logs and spreadsheets.
• Assisted the quality engineer in various quality compliance activities, as needed.
June 2008-February 2009 Aerotek Scientific, LLC, Piscataway, NJ
CONTRACT MEDICAL DEVICE CONSULTANT/ REGULATORY SPECIALIST
• Provides various quality compliance consulting and contracting to corporate, clients.
Dental Medical Device/ Pharmaceutical Manufacturer: Sultan Healthcare, Englewood/ Hackensack, NJ
June 2008- February 2009
• Conducted mock/internal/external FDA/ISO/MDD QSR audits of domestic manufacturing facilities within the medical device realm.
• Provided technical support, and regulations and standards support to the audit team.
• Performed in-depth process audits and data analyses, as required.
• Ensured corrective actions are effective in addressing the root cause to help prevent the recurrence of non-conformities.
• Performed statistical analysis such as process capability, trend analysis and process control
• Issue, as required, corrective action and preventive action on the processes
• Completed technical reviews and analyses of nonconformities, corrective actions and preventive actions (CAPA’s), and complaints as required. Prepare CAPA analyses and issue corresponding CAPA’s.
• Functioned as the back-up to the QA/RA Manager for review and approval purposes
• Maintained technical files and risk management files for all devices and pharmaceuticals. Responsible for organizing and scheduling periodic risk management reviews.
• Responsible for filing product registration applications and handling government interactions pertaining to the regulation process for registering products in the EU, Japan, Australia and Canada, when requested.
• Interfaced with customers, regulatory bodies (FDA, TUV, Health Canada) as required.
• Reviewed, analyzed, and communicated the effectiveness of Corrective and Preventive actions.
• Reviewed and provided QA technical support of ECN’s.
• Reviewed label content for regulatory requirements.
• Reviewed and approved manufacturing instructions, product and packaging specifications and provide technical assistance.
• Promoted and supported continuous improvement initiatives.
• Assured compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
July 2008- November 2008 Guideline/ Intota, Minneapolis, MN
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Provided technical consulting to corporate, legal and government clients.
• Provided professional consulting as a FDA Medical Device Quality Systems Consultant, Governmental Registration Process Consultant, International Business Consultant, GMP Consultant.
• Can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services in litigation areas as a FDA Medical Device Quality Systems, Governmental Registration, International Business, and GMP’s.
• Served as a resource to Intota Market Research Services for customized marketing research in industries or areas related to FDA Medical Device Quality Systems, Governmental Registration Process, International Business, and GMP.
Law Office (Confidential), Scherrillville, IN July 2008
• Analyzed, investigated, and reviewed associated documentation, labeling, and potential non-conforming combination pharmaceutical and medical device products. (Case settled due to my expertise.)
Law Office (Confidential), Redwood, City, CA July 2008- November 2008
• Analyzed, investigated, and reviewed depositions and associated MDR/ complaint, et al documentation pertaining to a potential non-conforming surgical medical device product. (Case settled due to my expertise.)
January 2008 – April 2008 Synthes, USA, West Chester, PA
REGULATORY COMPLIANCE AUDITOR
• Conducted mock/internal/external FDA QSR audits of domestic and foreign manufacturing facilities of Synthes, including supplier audits, within the medical device realm and advised firm officials on FDA enforcement policies.
• Completed quality records and/or prepared written procedures (such as pertaining to CAPA validation/verification of effectiveness reports) when requested.
• Evaluated product designs and manufacturing processes for compliance with regulations.
• Performed onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement.
• Established continuous process improvement at various levels at the organization.
• Extensive background in the enforcement of consumer protection regulations.
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act.
• Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits.
• Ensured that manufacturers’ employees have proper knowledge of applicable regulations.
• Developed and implemented business practices improving and reducing operating expenses of company sites (such as aiding in the creation of new device master records).
• Collaborated with site manufacturing personnel to gather information and explain findings.
• Conducted training sessions on inspection and investigation techniques and other related topics.
• Communicated with and maintained customer relations with facility personnel (such as during internal audits of other sites).
November 2007- December 2007 Oxford International, Beverly, MA
CONTRACT MEDICAL DEVICE QUALITY CONSULTANT
• Provided technical consulting to corporate clients.
• Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
Orthopedic Implant Manufacturer: Abbott Spine, Austin, TX- Nov 2007- Dec 2007
• Compiled data necessary to complete 21 CFR 803 MDR baseline reports.
• Reported to Quality and Regulatory management on bringing the MDR processes and product 510(k)/PMA files into FDA compliance for various class I/III orthopedic implants and accessories.
August 2007- November 2007 New World Regulatory Solutions, Inc. Tom’s River, NJ
INTERNATIONAL MEDICAL DEVICE CONSULTANT
• Provided technical consulting to corporate clients.
• Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
In-vitro Diagnostic Medical Device Manufacturer- Oxford Innumotec, LLC,
Oxford, England, UK- August 2007- November 2007
• Audited the QSM, Manufacturing, DHF deliverables for consistency and conformance. Review the current Risk management Plan, and all related deliverables.
• Recommended and setup management controls, design controls, CAPA and process validation protocols and Production Processes as part of the Quality Initiative Program.
• Audited, reviewed, and critiqued Vendor and Supplier Mfg process SOP’s, data and deliverables for accuracy, completeness, and Quality.
• Reported to the CEO and VP’s for recommendations on bringing the Manufacturing, Quality, Supply Chain and Design/Manufacturing processes and procedures into FDA compliance for a Class III PMA IDE IVD.
January 1985- February 2006 US Food and Drug Administration, Chicago, IL/ Pittsburgh, PA/ South Bend, IN
ANALYST/LEVEL II CERTIFIED INTERNATIONAL MEDICAL DEVICE INVESTIGATOR
• Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry.
• Conducted full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices and located throughout Canada and Europe.
• Evaluated product designs and manufacturing processes for compliance with regulations.
• Performed and documented numerous inspections, achieving enhanced compliance through various regulatory actions including warning letters and seizures.
• Established continuous process improvement at all levels in organization.
• Extensive background in the enforcement of consumer protection regulations.
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act.
• Experience in both the field ensuring FDA compliance as well as in the headquarters office.
• Worked (internal detail positions) as a field compliance officer, FDA HQ international medical device inspection planner, and FDA HQ International compliance officer.
• Ensured that manufacturers’ employees have proper knowledge of applicable regulations.
• Developed and implemented business practices improving and reducing operating expenses.
• Collaborated with manufacturers’ personnel to gather information and explain findings.
• Initiated legal actions against violators.
• Advised industry, state, and local officials and consumers on enforcement policies.
• Conducted training sessions on inspection and investigation techniques and other related topics.
• Communicated with and maintained customer relations.
• Served as team leader on complex assignments requiring the participation of multiple personnel.
• Fulfilled the duties of the Resident-In-Charge during an extended period of absence.
• Significant experience in making group presentations.
• Demonstrated skills in preparing comprehensive and easily understood written communications.
• Fostered team spirit and open communication on all phases of business.
• Developed approaches and procedures, which have improved the efficiency of agency operations.
• Level I/II Certified International Medical Device Investigator.
• Detroit District Medical Device Co-Leader – Indiana, *****.
• Detroit District Medical Device Team Leader, *****.
EDUCATION AND TRAINING
2010: ASQ Certified Biomedical Auditor (QBA)
2012- Present: Doctor of Business Administration, Concentration in International Business, Walden University (est. 2014 completion) (Online Study In Progress)
*****: MBA, Concentration in International Business, Indiana University
*****: Bachelor of Science, Metallurgical Engineering, University of Notre Dame
*****: Bachelor of Science, Chemistry, University of Notre Dame
TECHNICAL QUALIFICATIONS
MAC/PC Applications and MS Office (Word, Excel, PowerPoint, and Visio)
Additional training includes: Computer Aided Inspections, Computer Systems Validation, FMEA Workshop, Auditing Medical Devices, Medical Device Process Validation, Quality Audits for Improved Performance, Industrial Sterilization for Drugs/ Devices, and Orientation to International Inspections.
2010- ASQ Certified Biomedical Auditor (QBA)