When Things Go Wrong - Webinar CD/Transcript

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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.

  • Pharmaceutical
  • Biotechnology
  • Diagnostics
  • Drugs, Biologics
  • Radio-pharmaceutical
  • Pharmacies
  • Medical Device Industries

Charity Ogunsanya, who has 23 years of extensive experience within pharmaceutical, biotechnology, biologics, cell-therapy, diagnostics, research and development, radio-pharmaceutical, contract manufacturing organization (CMO) and medical device companies.

Throughout her corporate career in these diverse industries, she has held various high visibility and business critical roles within the quality and compliance division in major fortune 100 companies both as a subject matter expert (SME), site manager, multi-site manager and director.

She has been a sought after expert and been consistently hired after several competitive efforts by major fortune 100 companies to assume key roles specifically related to the startup, total overhaul, reorganization, restructure, compliance remediation, operational management, enhancements, process improvements, quality systems improvements and/or enhancements with production processes.