Aseptic Processing Design, Operations, and Controls | Aseptic processing is one of the most challenging tasks within pharmaceutical manufacturing. There are a wide range of human and equipment factors to keeping the process sterile and compliant. During this session, we review recent findings in warning letters from FDA on aseptic processes and deep dive into a case study on a combination product. You will learn firsthand from two FDA regulators who understand these challenges and deal with them. At the Q&A panel you have a unique opportunity to discuss the challenges you're currently facing and gain some actionable ideas and solutions to improve your own processes directly from the speakers.