Residence Inn San Diego Downtown/Gaslamp Quarter

Course Description: Every company regulated by the U.S. FDA establishes procedures, practices and an internal monitoring system all designed to both meet the regulations and manage inspections. However, many are surprised by Warning letters or more serious actions. Regardless of whether your company has been on the receiving side of a regulatory action or not, this course will help you in have better Quality systems, effectively managing and responding to FDA inspections. The first day will provide you with a better understanding of the FDA culture and the unique focus of FDA investigators during inspections. You will learn what are the observations and events that will signal to you that serious regulatory actions may follow. With prior knowledge, you can identify potentially serious deficiencies before an inspection in addition to responding quicker whenever serious issues are identified. The key to being “inspection ready” are effective written procedures, training programs and monitoring including internal auditing. The instructor having more than 40 years of experience with FDA and the pharmaceutical industry will on the second day share his perspectives on what can be improved in these systems. If you believe that any Quality system can be improved or at least that it is important to constantly re-evaluate whether your own systems, you will benefit from attending. Those benefiting include both those from the pharmaceutical and medical device industries. Events and observations from both industries will be used. Learning Objectives: -Understanding FDA's enforcement strategy and what it means to your firm -Understanding how auditors think and their expectations -Being prepared to receive regulatory inspections -Recognizing when inspectional findings or events indicate potential regulatory actions -When to take or not immediate action during an inspection -Making better responses to FDA both during and following inspections -How to make written procedures and training more effective -How to increase the effectiveness and efficiency of internal audits -How to identify effective compliance metrics Who should Attend: -Managers responsible for GMP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm's operations and monitoring of their state of GMP compliance -Individuals who come in contact with regulatory inspectors -Auditors -Compliance/Regulatory affairs professionals -QA/QC professionals -Senior management executives (CEO, COO, CFO, etc.) -Manufacturing managers, supervisors & personnel -Project Managers -Consultants