ED WINNETT has over 20 years of experience in the biotechnology industry. He has developed, executed, and directed the validation of sterilization and depyrogenation processes for manufacturing equipment, including small and large scale bioreactors (20,000L), vessels, transfer piping, autoclaves, filtration trains and ovens to meet FDA, cGMP and MCA requirements. His expertise includes the development of Validation Master Plans for equipment, utilities, manufacturing processes, computer systems and QC laboratories, validation management, project management, with specialized expertise in sterilization and cleaning validation.