Useful Web Links

  White Papers   Link
21 CFR Part 11 Industry Overview www.mastercontrol.com/PDF/lit/part11overview.pdf
21 CFR Part 11 Product Positioning www.mastercontrol.com/PDF/lit/part11positioning.pdf
21 CFR Part 11 Risk of Non-compliance www.mastercontrol.com/PDF/lit/part11risk.pdf
21 CFR Part 11 System Validation (Risk management plan) www.mastercontrol.com/PDF/lit/part11validation.pdf
DCS Literature www.mastercontrol.com/PDF/lit/mastercontrol_suite_all.pdf
Q & A released - Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach www.mastercontrol.com/land/email/21century_qa.html
   
  Other Sites   Link
CBER Guidance for CMC Human Somatic Cell Therapy INDs www.fda.gov/cber/gdlns/cmcsomcell.pdf
CBER Guidance for Human Somatic Cell & Gene Therapy www.fda.gov/cber/gdlns/somgene.pdf
CDER IND Application Process www.fda.gov/cder/regulatory/applications/ind_page_1.htm
CBER / CDER Phase I IND Guidance www.fda.gov/cder/guidance/phase1.pdf
CDER Exploratory IND Guidance www.fda.gov/cder/guidance/6384dft.pdf