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Clients get better results through outsourcing -  FDA submissions, procedure writing, validations, internal auditing, employee training, complaint handling (MDR), and CAPA projects. 

 GMP Compliance Services - Quality System Regulations

FDA Video - Quality System Regulations - Basic Introduction (105 minutes)

FDA Compliance Help Desk staff "roll up their sleeves" and work with you to assure cost effective compliance and the best quality assurance in the following areas:

  1. Determining the appropriate quality system needed to control design, production and distribution

  2. Designing products and processes (independent review)

  3. Training employees

  4. Acquiring adequate facilities

  5. Purchasing and installing processing equipment

  6. Drafting the master record noting how to change the master records

  7. Procuring components and materials

  8. Producing the products

  9. Labeling the products

  10. Evaluating finished products

  11. Packaging

  12. Distributing

  13. Processing complaints and analyzing service and repair data

  14. Servicing

  15. Auditing and correcting deficiencies in the quality system

  16. Preparing for an FDA inspection

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