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.
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.
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
Who Will Benefit:
- Food & beverage industry executives
- Dietary Supplement manufacturers/distributors
- Medical Device manufacturers/distributors
- In-House Legal Counsel
- Regulatory Affairs
- Government Affairs
- Distributors and manufacturers
- Customs brokers
- FDA/Food & Drug Attorneys
Course Provider
Marc Sanchez,
