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As the pharmaceutical and biotechnology industries increase utilization of continuous manufacturing, questions have arisen regarding the regulatory implications of implementing these technologies. FDA supports continuous manufacturing, and to facilitate use of new technologies and continuous improvement, FDA personnel will discuss the following topics in regards to continuous manufacturing: (1) Advantages/Disadvantages, (2) Importance of upfront design, (3) Role of process control, (4) Sampling considerations, (5) Related PAT principles, (6) CGMP regulations, and (7) Process validation.
|Continuous Manufacturing, a Regulatory Perspective|
Room: 1E12 ~ 10:00 am - 11:00 am (Tuesday, March 29, 2011)