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This presentation will: - Explain new and extended requirements in Annex 1 GMP guideline for Europe. - Compare new Annex 1 and FDA Aseptic Guideline from 2004. In the past, the FDA Guideline was much more detailed than the European one, but this is changing dramatically. - Identify how to upgrade existing BFS production to fulfill this new requirements. - Address how to practically integrate BFS in the contamination control strategy. - Discuss the difference in rotary and shuttle technology -- difference in sterility assurance? This is the first time a regulatory document shows the difference between two major technologies in BFS. - Cover how plastic material and sterility is a new important focus in the Annex 1.
