Training & Certification

Training & Certification

 

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FDA Compliance Services

Successful Quality Assurance programs integrate the four elements of Quality Systems, Training, Audits, and Technical and Regulatory Expertise to achieve compliance. Each of these elements taken individually, while important, is not sufficient to achieve and maintain compliance. Only by integrating all four of these elements into a medical gas firm’s quality systems, can you achieve and maintain compliance with FDA regulations.

Quality Systems in the form of Standard Operating Procedures establish guidance for compliant operations. Effective systems must ensure that all procedures encompass current FDA requirements and industry practices, and are maintained as requirements evolve.

CGMP Training Programs and Services provide the tools and support you need to conduct effective employee training. Our program covers both FDA compliance and medical gas operations, and provides tools to train members of the QC Unit, production employees, and drivers.

Audit Programs and Services provides a state of the art comprehensive tool and audit systems to identify issues of non-compliance in your business. Our audit system also assists you to implement and document corrective actions in accordance with FDA requirements.

Technical and Regulatory Expertise assures that business and quality managers have access to the same level of technical and regulatory expertise available from the major gas producers.