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FDA 21 CFR 820 Implementation

Gap analysis
Implementation project planning
Documentation review
On-line support
Certification audit assistance
FDA 21 CFR 820 Implementation


FDA 21 CFR 820 QSR Implementation Program

  • Ready to start your FDA 21 CFR 820 QSR implementation?

  • Puzzled where to start?

  • Not clear on how to interpret FDA 21 CFR 820 requirements?

Quality Works can help!  In addition to our Documentation Set, Quality Works offers assistance to jump start your FDA 21 CFR 820 implementation project.  Our consultants will help you to assess what you already have in place, develop an implementation plan, interpret requirements of FDA 21 CFR 820 and show you the best way to add new processes in order to meet the requirements of FDA 21 CFR 820. The program includes hands-on project support from your very own FDA 21 CFR 820 consultant plus our entire documentation set and training tools.  This program is designed to maximize your limited resources by using tested tools and the subject matter expertise of our consultants. This 10 hour on-line program includes:

  • FDA 21 CFR 820 QSR compliant Documentation Set,

  • The Perfect Manual book,

  • Gap analysis

  • FDA 21 CFR 820 Implementation Plan

  • Set-up of your documentation structure,

  • Guidance on customization of your key processes.

Our on-line programs are conducted on the phone or Skype and can be customized to meet your company's specific needs. This FDA 21 CFR 820 implementation program will ensure that your project is successful and your staff develop the skills necessary to implement and maintain your new FDA 21 CFR 820 quality management system.

Order your Implementation Program today or Call us to discuss your specific management system needs!

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