Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions
Thursday, January 17, 2013 at 7:30 AM - Friday, January 18, 2013 at 5:00 AM (PST)
San Francisco De Macorís, Dominican Republic
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.
- 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
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.