ASTM International Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products, in partnership with the Food and Drug Administration (FDA) is sponsoring a workshop on Current and Future Standards Activities within Pharmaceutical and Biopharmaceutical Manufacturing, Oct. 11, 2016 at the FDA, White Oaks Campus, Silver Springs, Maryland, USA. The workshop will take place in conjunction with the October standards development meetings of the committee.
The workshop is designed to share Committee E55’s mission, accomplishments, roadmap for the future, and to understand the FDA expectations about quality and operational standards. The workshop will also include interaction sections with participation of industry leaders and FDA representatives on four topics:
- Viral filtration,
- Data management,
- Single Use systems, and
- Continuous manufacturing.
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