Institute for International Research

PTi international, an IIR sister company, launches a timely webinar on July 30th, "Managing and Preparing for the FDA Inspection"

Amidst continuous FDA changes, it is imperative for all FDA regulated businesses to update internal risk-assessment and risk-management strategies to become current and compliant with new Agency Pharmaceutical cGMP inspection focuses.  

Just recently, two groundbreaking programs were announced by U.S. Health and Human Services (HHS) Secretary Mike Leavitt, focused on ensuring the safety of food and medical products exported to the United States.  "These programs will significantly increase our collaboration with international and private sector partners to enhance the safety of imported food and medical products," Secretary Leavitt said. "Working together, we intend to offer expedited access to those products shown to meet our standards and to focus more of our resources on those products that present higher risks."

This intensive web information session will delve into the current processes and areas of greatest interest to the FDA, to help you become current and compliant with new Agency Pharmaceutical cGMP inspection focuses.  You will review the sub-systems within the six Quality Management Systems and gain a solid understanding of how they set the Audit Trail.  This knowledge is crucial in anticipating FDA expectations and will help lead to a successful inspection. 

For more information, or to register, please visit the official webinar site:
http://www.pti-international.com/newinspection/index.xml