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On April 19-20 in San Diego, CA, PDA will hold the first of a series of four global interactive workshops to address new developments in aseptic processing. The 2016 PDA Workshop: Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision will provide a forum for industry and regulatory professionals to discuss science- and risk-based approaches that support modern aseptic processing and control strategies. This Workshop will facilitate the use of critical thinking to better understand the aseptic process and the associated risk of contamination, and how to develop optimal process control strategies. Industry and regulatory experts from around the world will explore the critical topics within the scope of the new revision of the EU GMP Annex 1, including:
Be a part of the discussion that will impact the global manufacturing of sterile medicines for decades to come.
PDA Education’s GMPs for Manufacturers of Sterile and/or Biotechnology Products course will be conveniently held following and at the same location as the April Workshop. Register for this course to gain a better understanding of the regulatory expectations for equipment and utility qualification and sterile process validation to ensure that the products manufactured in your facility are proof-positive sterile. |
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