Validation and compliance services in FDA regulated industry

Quality Management

1. Quality System Documentation

  • Assist Companies establish ISO 9000 Quality System documentation
  • Assist Companies establish ISO 13485 Quality System documentation for medical devices
  • Gap analysis for either ISO 9000 or ISO 13485
  • Assist each function in the company identify important documentation
  • 2. Audit Services

  • Internal Quality Audits
  • External Quality Audits of your suppliers.
  • 3. ISO 9000 Training Programs

    On-site training programs. see quality training courses .

    4. Quality Training Programs

    Quality training courses are designed to provide the latest concepts in quality engineering such as:

    Root Cause Analysis

    Quality Improvement Process

    Six Sigma, Cost of quality , CAPA ,TQM

    5. ISO 9000 and ISO 13485 Implementation Programs.

    Accelerated implementation programs (A.I.P) have been developed for small , medium and large size organizations, and are generally composed of training and implementation consulting.

    6. Six Sigma and Lean manufacturing

    Training and special implementation programs are offered for the pharmaceutical industry

     

    This document is maintained by webmaster@progamma.ca.
    Copyright ©1998-2019 proGamma Science Corporation