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Francis Godwin

Compliance Officer

FDA


Speaker Bio

Francis Godwin received his undergraduate degree from MIT in Chemical Engineering. He worked as a process engineer in the chemical industry, and is certified as a black belt in Six Sigma. He moved into pharmaceutical process validation where he worked on both batch and continuous processes. He then ran an analytical chemistry lab dealing with both production and research testing. Recently he received an MBA from Georgetown University and now works as a Compliance Officer for FDA in CDER's Office of Compliance, Division of Manufacturing and Product Quality. Mr Godwin is listed as a subject matter contact for Corrective Action/Preventative Action and for Continuous Manufacturing.

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Tuesday, March 29, 2011
Conference Program
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Continuous Manufacturing, a Regulatory Perspective
Room: 1E12 ~ 10:00 am - 11:00 am (Tuesday, March 29, 2011)
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.
Francis Godwin - Compliance Officer, FDA
Reed Exhibitions
  • Pharmaceuticals
  • Biologics
  • Generics
  • Contract Services
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