Interested parties can register at http://www.asepticprocessing.co.uk/PRCOM5. Register by
Ahead of the conference,
A teaser of what
The Aseptic Processing industry has matured significantly in previous years, what key developments have you witnessed in the last year within the field?
“There is definitely a trend to a higher degree of automation and less direct operator involvement in all parts of aseptic processing. Increased usage of barrier technologies and in particular isolators are another example of recent years key development.”
What are your thoughts on the developing regulatory environment in this field and how is this impacting your work at the moment?
“When it comes to the revised Annex 1, which is currently the most apparent regulatory development, there is definitely an impact to work. Significantly increasing the Annex 1 document size, getting agreement with many stakeholders from different authorities and industry interest groups is a huge task. There are many different sterile product types and manufacturing technologies where the requirements need to be adapted to and where there needs to be technical solutions available for their implementation. In the end all want to achieve the best possible final Annex 1 document that is fit for its intended use and really benefits patients that in the end will receive the product.”
Alexander will be speaking at the conference on day-one on How to Prepare and be Ready for the Revised Annex 1 - A Pharmaceutical Company Perspective.
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