Subscribe

  • How Can We Help You?

    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Katz_Paula_1000x714_ENV

Paula R. Katz

Of Counsel

Washington +1 202 662 5050

  • About
  • Representative Matters
  • Credentials
  • About

    Paula Katz advises clients on pharmaceutical compliance and enforcement. 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, administrative law and procedure, and regulatory policy development and enforcement strategy.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advice on FDA inspection responses, including several that successfully resulted in VAI classifications at those sites, interactions with regulatory authorities, and managing compliance and enforcement actions.
    • Conduct investigations into potential GMP or GCP violations.
    • Advice on regulatory issues in their commercial agreements, including ancillary agreements such as Quality Agreements and Pharmacovigilance Agreements.
    • Regularly counsel on drug and biologics recall issues.

    Areas of Expertise

  • Credentials
    Education
    • University of Virginia School of Law, J.D., 2005
        • Virginia Journal of International Law, Editorial Review Board
    • University of Virginia, B.A., 2001
        • highest distinction
    Bar Admissions
    • District of Columbia
    Government Experience
    • U.S. Department of Health and Human Services – Food and Drug Administration
    Memberships and Affiliations
    • Parenteral Drug Association
    • Food and Drug Law Institute
    • International Society of Pharmaceutical Engineers
    Previous Experience
    • U.S. Food and Drug Administration, Director, Manufacturing Quality Guidance and Policy Staff

    Areas of Expertise

News and Insights

Events