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The work of the 340 scientists and support staff at BASF Bioresearch Corp. (BBC) in Worcester, Massachusetts, concentrates on new treatments for autoimmune diseases, prevention of transplant rejection and biopharmaceutical contract manufacturing. Joshua Froimson is BBC's quality engineering manager. For this presentation, members of his audience come from all areas of the biopharmaceutical manufacturing operation, and his goal was to introduce and explain BBC's validation program. His slides are critiqued and updated.