FDA Warning Letter Management
Duration: 60 Minutes
A Warning Letter gives you legal notice of possible legal action against you by the FDA. A Warning Letter from the FDA requires a prompt, thorough and realistic response to mitigate further damage to your business. If you do not respond effectively, you face a long and costly task of rehabilitating your FDA regulatory profile with the agency, your customers and your investors. You need to understand how to manage the FDA's Warning Letter to control the possible skyrocketing cost of noncompliance. The FDA warning letter can quickly start to manage you unless you already have in place a plan to manage the Warning Letter. "A stitch in time saves nine."
When the FDA documents that a firm has significant deviations from applicable legal requirements, it will issue that firm a Warning Letter. As an enforcement tool, the FDA Warning Letter tells you that your firm is facing harsh enforcement action unless you correct the errors of your ways. What you say and, more importantly, what you do can make or break your future with the FDA. The Warning Letter is a regulatory spring board that leads you into treacherous waters. Currently, the FDA aggressively manages Warning Letters. The threat of further legal action is real. You have little, if any, breathing room for mistakes or oversights in your response. By effectively managing your Warning Letter response, you can avoid being a statistic for other legal actions, like seizure, injunction, prosecutions, fines and product detention.
Why Should you Attend:M
The risk of receiving a Warning Letter should prompt you to develop a plan of action before the "bad news" is actually delivered. Once you receive a Warning Letter, you face short and rigid time deadlines, a credibility issue with the FDA and painful consequences in terms of time, money and reputation. An effective Warning Letter response can mitigate most of the inevitable damage. On a more positive note, a firm can develop and implement an impressive change in its regulatory program and apply it going forward to other areas. It happens.
Objectives of the Presentation:
Who can Benefit:
- Gauging the likelihood of receiving a Warning Letter
- Preparing for a Warning Letter
- Interpreting a Warning Letter as a "micro" and "macro" problem
- How and when to respond a Warning Letter
- Interacting with FDA staff
- Immediate, intermediate and long term business impact
- Warning Letter Post Mortem
- Mapping your regulatory future.
Live Session - How it works
- Regulatory Affairs Managers
- Quality Assurance Managers
- Legal Counsel for Product Liability
- Sales and Marketing Executives
- Finance Executives
- Manufacturing Executives
- Design Engineers
- Third Party Consultants
Recorded Session - How it works
- We will send Username and password 24 hours prior to webinar at your email address.
- Webinar presentation handouts will be shared in pdf format, a day before live presentation.
- Use the login details to participate in sessions.
- Clear out your queries through interactive Q&A chat boxes with the speaker.
- We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
- Get certification of attendance.
- Once you purchase a webinar you will receive username and password at your email address.
- Use the login details to view recorded webinars.
- Presentation handouts will also be shared in pdf format.
- Access to the recording is valid only till 6 months starting from the date of purchase.
- Get certification of attendance.