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Experience

    • President
      • May 2015 - Present

      Dedicated to providing the Pharmaceutical industry with a professional approach to assure regulatory compliance to all facets of validation, testing, manufacturing, stability, storage and process transfers. Site assessments are systematic and remediation efforts are thorough to meet applicable regulatory agencies requirements. Lou Da Silva, President provides expert Compliance/Quality Consulting with over 35 years experience in the Medical Device and Pharmaceutical industry. Areas of expertise include Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Extensive knowledge of QSR design control requirements. Experience includes implementing audit programs, developing and reviewing procedures, evaluating the effectiveness of quality systems, and assisting in the development of compliance strategies, due diligence audits, pre-approval audits and inspections/training, CAPA responses to regulatory deficiencies and remediation. Additionally, experience in Technology Transfers to other facilities and third-party manufacturing sites. Strengths include analyzing and problem solving compliance related system issues.

    • Principal Consultant
      • Jan 2004 - 2015

      Provide expert compliance input to the Healthcare industry. Provide expert compliance input to the Healthcare industry.

    • Colombia
    • Personal Care Product Manufacturing
    • 200 - 300 Employee
    • Sr. Site Compliance Manager
      • 2001 - 2004

Education

  • Northern Illinois University
    B.S., Chemistry & Biology
    1970 - 1974

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