Chris Watts, Ph.D. is a Partner within the Consulting Group in NNE Pharmaplan and heads the company's Quality and Regulatory group in North America. Chris holds a Doctorate in Pharmaceutical Science from the University of Tennessee, and a Baccalaureate in Biomedical Engineering from Boston University. He recently joined NNE Pharmaplan from the FDA, where he was part of the team developing policies and systems for the Agency’s science and risk-based approach to CGMP inspection and CMC application review, including the recent guidance on Process Validation. Prior to the FDA, Chris was responsible for the development and manufacture of NCE and biotech products at Dura Pharmaceuticals and Shire Laboratories. Chris has been engaged in several quality and regulatory projects, from developing risk-based approaches for product and process development, to strategies and systems for quality management.