Ali Afnan

  PhotoDr. Afnan was recruited in 2003 by FDA to join the Agency’s PAT and Drug Product Quality initiatives. He was a member of the PAT steering team and a co-author of the PAT Guidance, member of the core team responsible for authoring and finalizing the most recent Guidance from FDA on process Validation. He left the FDA in March 2010. Dr Ali Afnan began his career in ICI Engineering as a control-electrical engineer, and then joined the engineering group in AstraZeneca. He led the development and implementation of a PAT framework for a solid dosage facility- the first such facility in industry. He is the recipient of several FDA Commissioner Awards, as well as the Industrial Pharmaceutical Federation’s Industrial Pharmacy Medal of Excellence award. Ali is the president of Step Change Pharma, Inc. offering a range of consultancy services offering Pharmaceutical Manufacturing Excellence. He writes for and Pharmaceutical Manufacturing magazine. (FR Brussels October 2012)