Useful Web Links

  White Papers   Link
21 CFR Part 11 Industry Overview
21 CFR Part 11 Product Positioning
21 CFR Part 11 Risk of Non-compliance
21 CFR Part 11 System Validation (Risk management plan)
DCS Literature
Q & A released - Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach
  Other Sites   Link
CBER Guidance for CMC Human Somatic Cell Therapy INDs
CBER Guidance for Human Somatic Cell & Gene Therapy
CDER IND Application Process
CBER / CDER Phase I IND Guidance
CDER Exploratory IND Guidance