Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall
Friday, August 9, 2013 from 10:00 AM to 11:00 AM (PDT)
This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.
Why Should You Attend:
- How do you deal with a difficult compliance officer or recall coordinator?
- How do you know when to push back, to cry foul, or ask for the district compliance director to be involved?
- When should you make legal arguments and challenges?
Inspections by the FDA are perhaps the most intimidating and stressful of all events at a regulated facility. That stress can be amplified exponentially when dealing with a difficult compliance officer or recall coordinator.
Many industry 483 observations shouldn't have been received at all. Most Warning Letters could have been easily prevented. Responses can be compounded and the time to a close out letter drawn out.
During this session, you will learn how to work with a difficult compliance officer and resolve tricky compliance situations before any damage can be done. We will also explore common scenarios that can cause compliance difficulties for you and what you should do to avoid them. At the end of the webinar, the instructor will answer any and all questions specific to your industry or facility. Attendance to this training will be limited to ensure every participant gets time for interacting with the speaker.
The instructor is an attorney and a veteran with extensive experience in working with both the FDA and USDA on compliance, recalls, and import matters.
Areas Covered in the Webinar:
- 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.
- When to make legal arguments and challenges
- How to cry foul to the district compliance officer
- Meeting requests and other tools to ease tensions
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.