PAULA R. KATZ is of counsel at Covington & Burling where she advises clients on life sciences compliance and enforcement. Paula’s practice spans GxP issues, with special focus on guiding clients through product quality and manufacturing challenges, regulatory inspections and responses, and regulatory aspects of life sciences transactions such as quality and safety data agreements. She joined the firm after serving as Director of Guidance and Policy for the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). While at the FDA, Paula focused on current good manufacturing practice (CGMP) enforcement and drug quality policy issues. She advised CDER and FDA leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, and regulatory policy development and enforcement strategy.