When Things Go Wrong - Webinar CD/Transcript
When Things Go Wrong: Overcoming Compliance Issues in 483s, Warning Letters and Consent Decrees
Every drug and device maker dreads the day the FDA investigator will come.
Take a few false steps and your 483 could become a warning letter … or even worse, a consent decree.
An oversimplification? Of course.
A real possibility? Yes … this could happen to you.
Before you find yourself on the losing end of a 483, warning letter or consent decree, there's a preemptive course of action for you to consider. Listen to the audio CD/Transcript of the FDAnews virtual conference When Things Go Wrong: Overcoming Compliance Issues in 483s, Warning Letters and Consent Decrees.
This audio CD/transcript is designed to help drug and device manufacturers like you avoid situations in which manageable compliance issues unexpectedly spiral out of control, turn into a corporate nightmare and unnecessarily cost your company millions of dollars.
During in-depth sessions, you'll hear real examples about what leads to 483s, warning letters or consent decrees … what wasn't done correctly in addressing compliance-related issues … what happened when proven and effective resolutions were incorrectly applied … and where best practices for handling issues should have been applied, but were NOT.
In just a few hours, you'll have a keener understanding of the kinds of errors you must avoid, based on other companies documented problems.
For just a small registration fee, you'll learn invaluable lessons from their costly mistakes and failures. You'll gain a detailed and clearer understanding of the following:
- The progression and severity of the various FDA compliance findings, what triggers should you be watching for
- What companies are doing “right” and “wrong” when they are presented 483 findings, warning letters or consent decrees
- The reasons why some companies with recurrent unresolved 483 findings end up with warning letters and/or consent decrees and why some don’t
- Effective steps in resolving 483s, warning letters and how long you have to respond before real trouble starts
- Examples of various scenarios and players caught up in the consent decree process — how it started and how they resolved it
- The exploding amount of “soft costs” due to compliance failures —recalled products, additional regulatory filings, sagging employee morale and poor business reputation
Those in your organization with a role in quality assurance/quality control, operations, manufacturing, materials management, purchasing, packaging and labeling, plant engineering, laboratory quality control, regulatory affairs will benefit from taking part in this event — and they can do so at a cost that won’t break the budget. You pay a single low registration fee per line, regardless of how many participate. So spread the word.