PDA Workshop: Current Challenges in Aseptic Processing, Potential Changes 2016

The 2016 PDA Workshop: Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision will present the experts’ perspective on the points to consider in addressing the most frequent questions raised in the interpretation of applicable regulations for aseptic processing, as well as related recommendations of best practices for sterile product manufacturing. This Workshop will explore the critical topics within the scope of the new revision of the EU GMP Annex 1, which will impact the global manufacturing of sterile medicines for the next decade or more. Session topics will address the most difficult issues companies are currently facing, based on recent inspections and process performance history.