Alfonso C. Fuller, Jr.
David DuRocher
Denis M. Kluba
Thomas A. Mitchell

Alfonso C. Fuller, Jr

  • Principal Consultant

    Mr. Fuller specializes in quality system, regulatory, enforcement and compliance matters for FDA regulated medical device, pharmaceutical and biotech manufacturers, suppliers, importers and vendors. Having practiced in Washington, D.C., Mr. Fuller is highly experienced in communicating with FDA headquarters and field staff. Mr. Fuller has specialized in regulated industry for over 25 years.

    Quality System Consulting

    • cGxP, GMP, GLP, GCP, GAMP audits, compliance and remediation
    • Program and project manager for many Fortune 500 manufacturers
    • Interpretation and implementation of 21 CFR Part 11, 58, 210, 211, 820, etc
    • Seminar speaker and trainer (public and on-site training available)
    • Vendor / supplier audit and training
    Computer Systems / Software Validation
    • Computer systems programmer, tester, validation engineer
    • Systems inventory, audit, gap analysis, implementation, remediation
    • Software quality auditor, reviewer, SQA manager
    FDA Compliance and Enforcement
    • Response and prevention regarding FDA compliance and enforcement matters
    • Pre-audit preparation and post-audit response
    • FDA enforcement and compliance expert: FDA-483, warning letter, consent decree, seizure
    David DuRocher
  • Affiliated Consultant

    Mr. DuRocher has over 20 years experience as an automated systems developer, programmer and tester, and specializes in software compliance for FDA-regulated companies. His skills include validation planning, IQ / OQ / PQ drafting and execution, as well as 21 CFR Part 11 expertise.

    Computer Systems / Software Validation

    • Programmer and software validation engineer
    • Project manager
    • cGMP and 21 CFR Part 11 audit, gap analysis, remediation

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    Denis M. Kluba
  • Affiliated

    Mr. Kluba has over 30 years experience as a program and project manager, utilities and systems validations expert, and compliance manager for FDA regulated biotech, medical device and pharmaceutical manufacturers.

    Mr. Kluba has an extensive career of consulting specializing in integrating compliant manufacturing and quality system practices into pharmaceutical and medical device manufacturing organizations. Mr. Kluba? experience spans large and small international engineering firms? compliance groups and a specialized regulatory consulting group as a consultant and manger of technical projects. His career also includes experience with project and operations management, functional development of compliance solutions within manufacturing operations and managing consulting specialist. This background provides the ideal credentials to understanding CGMP requirements, FDA inspection expectations and the functions necessary to meet regulatory compliance requirements while efficiently manufacturing products. Mr. Kluba? specialty is the cost effective integration of cGMP compliant requirements into projects and systems.

    Mr. Kluba? past projects include facilities, equipment and utilities qualification for API, finished pharmaceutical and biotech production, including review and development of design documents and drawings, environmental monitoring program methods and procedures, cleaning validation, utilities support, qualification protocols, packaging protocols, computer systems qualifications and process validation.

    Mr. Kluba was also the Compliance Project Manager for multiple large-scale facility constructions. Each projects benefited from Mr. Kluba? experience in lower costs, on-time performance and FDA approval of the facilities

    Mr. Kluba has continued to implemented this same general philosophy in a number projects in Europe and the USA. His approach generates success of both the original project and the ongoing operations, saving capital, bringing operational efficiency, and imparting a pro-compliant attitude into the operations.

    Mr. Kluba holds BS and PDD (masters level) degrees, both in engineering management, from the University of Missouri-Rolla.

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    Thomas A. Mitchell, Ph.D
  • Affiliated Consultant

    Dr. Mitchell specializes in computer security, information security and project management.

    • Project/program management (GMP and non-GMP environments)
    • Information systems project and program management
    • Software quality and validation
    • Quality systems and compliance consulting for biopharmaceutical, medical device and pharmaceutical industries
    • Strategic and tactical organizational consulting to senior managers
    • Business progress re-engineering
    • Computer systems and automated process controls validation and training
    • Vendor and supplier audits
    • Gap assessments

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