Resources

• Combination Products: A Regulatory Perspective
  by Kathy Lee, M.S., Associate Chief, Laboratory of Biochemistry, DTP/OPB/OPS/CDER/FDA
• Process Validation, FDA's 2011 Guidance
  by Ali Afnan, Step Change Pharma, Inc.
• Minimizing risk in your raw material supply chain (445 KB)
  by John Hollenbach, Director of Sales & Marketing Doe & Ingallas of North Carolina
• Aseptic Processing Risk Assessment: The Simplified Akers-Agalloco Method (257 KB)
  by James Agalloco, Agalloco and Associates and James Akers, Akers Kennedy and Associates.
• A Response to 'FDA Perspective on Approaches for Complying with CGMPS During Phase I INDs: Draft Guidance for Industry (170 KB)
  by Barry Friedman, PhD, Director, Quality Control, Cambrex Bio Science-Baltimore
• FDA Perspective on Approaches for Complying with CGMPS During Phase I INDs: Draft Guidance for Industry (551 KB)
  by Laurie P. Norwood, M.S., Chief/MRBII/DMPQ/OCBQ, Center for Biologics Evaluation and Research
• It’s a Bird, It’s a Plane, No Wait, It is Finally Multi-Center Current Thinking on Parametric Release of Drug Products Terminally Sterilized by Moist Heat (490 KB)
  by Marla Stevens-Riley, PhD
• Risk Assessment Principles for the Product Quality Initiatives (887 KB)
  by H. Gregg Claycamp, Ph.D., CHP, FDA
• Dispelling the Myths of Cleaning Validation (99 KB)
  by Destin A. Leblanc, CLEANING VALIDATION TECHNOLOGIES
• Preparing for the Pre-Approval Inspection: What to do Before the FDA Arrives
  by Barry Friedman, PhD, Consultant, Biotechnology and Aseptic Processing