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FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance
Friday, March 8, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.
Why Should You Attend:
Many industry 483 observations shouldn't have been received at all. Most Warning Letters could have been easily prevented. Yet the last few years have seen several major "names" in drugs, devices, and food stumble over GMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. If 483's are received, how can Warning Letters be avoided? If a warning letter is received, how can you demonstrate compliance to the FDA? How to address FDA District and Center concerns?
During this webinar, you will learn:
- Outline of FDA enforcement and compliance scheme.
- FDA inspection process.
- Lead up to a warning letter - warning signs.
- Warning letter issuance.
- Company response to FDA warning letters.
- What to avoid when dealing with FDA warning letters.
- Correcting FDA warning letter closeout mistakes.
Areas Covered in the Seminar:
- Warning Letter response.
- Top Ten Findings in Food, Dietary Supplements and Medical Device.
- Common mistakes when responding to the FDA.
- What actions to take to demonstrate compliance.
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.