On August 6th, FDA Commissioner Margaret Hamburg outlined the agency’s new enforcement strategy and her plan for creating “a strong FDA.” With greater scrutiny and a more streamlined enforcement process, it is critical that firms be prepared to respond and take corrective action quickly upon receiving a warning letter. This audio conference is designed to help senior life science executives understand what the new strategy means to them, how to maximize the chances that an FDA inspection will not trigger additional agency enforcement action and, if it does, how to respond.

This audio conference covers:

• The new accelerated and streamlined warning letter process
• Systematic follow-up after enforcement actions: the end of prolonged negotiations between companies and FDA and repeated warning letters
• The new formal “close out” process in which FDA recognizes that a firm, when applicable, has resolved the issues from an inspection
• What you can do to prepare for and properly reply to FDA inspections and warning letters
• Understanding the consequences of inaction or inadequate action
• How aggressive will FDA be under its new leadership?

About the speakers:

Matthew Weinberg is Chief Executive Officer at The Weinberg Group, an international scientific and regulatory consulting firm. Mr. Weinberg’s area of expertise is in compliance and quality management, with an emphasis on providing strategic and operational assistance. He helps clients improve their manufacturing processes and serves as a testifying expert on compliance-related matters.

Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. His expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis management, FDA regulatory activities, labeling and advertising, and clinical research efforts. Mr. Swit develops and ensures the execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.

Who should attend?

• Clinical Operations
• Marketing/Communications
• Quality Assurance/Quality Control
• Regulatory Affairs
• Legal Counsel

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.