Paula Katz

Of Counsel
Covington & Burling
 

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 CDER at FDA. While at the FDA, Ms. Katz focused on 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.

 

Sessions: 

Will Your Vendors/Suppliers Pass FDA Inspection? Understanding Oversight Responsibility