This hy-flex course addresses important issues related to development, quality, clinical, manufacturing and regulatory aspects of pharmaceuticals and the course provides important information on strategies for these areas.  The course is introductory in nature and is intended to address many basic aspects of the topic areas.  Product and process design will be addressed as well as quality by design (QbD), strong development reports, and excellent regulatory submissions and continuous improvement.  The course includes on line sessions, synchronous sessions, laboratory exercises, laboratory tours, and/or workshops.

Modern pharmaceutical companies must conduct drug discovery, development, manufacturing and marketing in a highly regulated environment with increasing competition and pricing pressures.  Systems for quality manufacturing, quality by design of manufacturing processes, process analytical technology, and on-line measurement are critical elements for success in this complex and evolving environment.  The cost of poor quality and the penalties for non-compliance are unacceptable in today’s drug development business.  Knowledge of effective quality manufacturing principles and practices is critical to getting things right the first time. This course will provide information on best-in-class methods for quality manufacturing, quality by design and formulation. 

The rationale of the course is based on the concept that high quality and appropriate compliance (QA/QC) are essential for the viability of industry, and academia as well.  Almost daily, examples come to light showing the downside of poor quality or compliance:  operations or organization closed, fines levied, careers affected, public images besmirched, credibility lost.