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References

Industry websites, Praxis training materials and webinars  and other reference materials related to computer system validation and software compliance.

Resources:
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FDA 483 Summary for Fiscal Year 2010 FREE
  • FDA Enforcement Statistics
  • References
ValGenesis Product Review
  • Product Review
  • References
Computer System Validation Course Presentation
  • CSV Boot Camp Documents
  • References
Computer System Validation Issue Log (class exercise)
  • CSV Boot Camp Documents
  • References
FDA Enforcement Statistics 2009
  • FDA Enforcement Statistics
  • References
FDA Enforcement Statistics 2010
  • FDA Enforcement Statistics
  • References
FDA Enforcement Statistics 2011
  • References
  • FDA Enforcement Statistics
FDA Enforcement Story 2001
  • References
  • FDA Enforcement Statistics
FDA Enforcement Story 2002
  • References
  • FDA Enforcement Statistics
FDA Enforcement Story 2003
  • References
  • FDA Enforcement Statistics
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