Pharmaceutical Lifeline - January 2007 Articles


Articles January 2007
  • Using Good Systems Practice to Right-Size IT Services for Emerging Biotech Firms - If you're looking to improve a single area in your FDA compliance program, look no further than your quality control unit.
    Full Article

  • QCU Issues: Top Reason for FDA-483 Citations Among Drug Companies - If you're looking to improve a single area in your FDA compliance program, look no further than your quality control unit.
    Full Article

  • Preparing for FDA Inspection Full Article
  • Inside Look at FDA Inspections
    Full Article

  • FDA Clinical Investigator Site Inspections Full Article
  • FDA Inspection of Foreign Manufacturers
    Full Article

FDA Links

  • Final Guidance – Quality Systems Approach to Pharmaceutical CGMPs
    Link

  • Compliance Program Guidance Manual for FDA Staff – Drug Manufacturing Inspections
    Link

 

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