LINKS AND DOWNLOADS

Below you will find our clients’ most requested documents available for download.  If you need any document that does not appear on this list, we will gladly help you find it.  Send your request by clicking HERE.

• • Farmaforum 2019 US FDA
  • Pitfalls-and-Pratfalls
  • Farmaforum 2018 US-EU Harmonization
  • Serious About Samples
  • Importance of the CAPA System – BEC Presentation
  • Data integrity FDA Expectations and Guidance – BEC Presentation
  • Jail Time for an Error (human error!)
  • Preamble of 21 CFR 210 & 211
  • Preamble of 21 CFR 820
  • FDA QSIT Guide
  • FDA Quality System approach to Pharmaceutical cGMP
  • FDA Guide to inspection of QC Labs
  • FDA Human Factor Guidance for Medical devices
  • ICH
  • www.eCFR.gov – U.S. government regulation documents
  • www.calidadpr.com – web page in Spanish
  • ASQ  – American Society for Quality, the leading global organization for quality.
  • RAPS – Regulatory Affairs Professional Society
  • PDA – Parenteral Drug Association
  • AAMI – Association for the Advancement of Medical Instrumentation
  • ISPE – International Society for Pharmaceutical Engineering
  • FDA – General page for the Food & Drug Administration
  • FDA Guidance’s Page – All Guidance documents for the FDA
  • FDA Warning Letter Page
  • FDA Weekly Enforcement Report
  • FDA – Freedom of Information Act