Learn the answer to these and other questions at the 2015 PDA Aseptic Processing –Sterilization Conference, where you have unrivaled access to expert knowledge related to current issues in aseptic processing. A whole Ask the Experts session has been set aside, so you can engage global and national regulatory and industry experts regarding trends, issues, solutions and best practices in the manufacture of sterile products.


This conference will highlight contemporary approaches for sterile product manufacturing using case studies and personal experiences from industry and regulatory experts, including Closing Keynote Speaker Nélio Cézar de Aquino, Deputy General Manager, Health Inspection, ANVISA.

• Innovative and best demonstrated practices in the following areas will be presented: Points to Consider for Aseptic Processing and EU Annex 1 – Take a first–hand look into the proposed revised aseptic processing points to consider followed by an interactive surveillance of current practices as it relates to the proposed revision of the EU ANNEX 1.
• USP <797> - Gain an understanding of regulatory changes resulting from a 2012 outbreak of Fungal meningitis, traced back to three packaging lots of methylprednisone manufactured by New England Compounding Center.
• FDA Aseptic Processing Guidance Document (2004) – Learn about known misinterpretations of the FDA Aseptic Processing Guidance Document (2004) and practical insight to prevent occurrence from industry and regulatory experts from India and Brazil who will provide a global perspective
  
  

Continue Your Education with the 2015 PDA Aseptic Processing - Sterilization Course Series


Immediately following the conference, on June 11-12, PDA will host four education courses to expand your learning on everything from process simulation testing to parametric release. For more information and to register for the 2015 PDA Aseptic Processing−Sterilization Course Series, visit www.pda.org/sterilizationcourses.