Mike Sadowski Baxter

Michael (Mike) Sadowski is a Lead Scientist, leading the Sterility Assurance (SA) Community of Practice at the Baxter Healthcare Corporation. He is responsible to ensure the continued connection and strengthening of the SA Critical Competency in support of pharmaceutical products and medical devices across the globe. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization modalities. In addition to participation as an Author in the revision of PDA TR No. 1 on Moist Heat Sterilization, he was the Chairman for the revision of the PDA TR No. 30 on Parametric Release. Mike previously served as Treasurer, Secretary and Director on the PDA Board of Directors and as a member of the PDA Scientific Advisory Board, currently serves an Associate Editor for the PDA Journal of JPST and Co-Chair of AAMI WG03 on Moist Heat Sterilization. Within these roles, he has successfully aligned industry and regulatory agencies to shape best practice. Mike continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. He is frequently sought as an expert speaker by global industry and regulatory sterilization professionals. Mike received his B.S. Degree in Microbiology from Purdue University.