FDAnews Announces — When Things Go Wrong: Overcoming Compliance Issues in 483s, Warning Letters and Consent Decrees Virtual Conference, Dec. 12, 2014

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This virtual conference is designed to help drug and device manufacturers avoid situations in which manageable compliance issues unexpectedly spiral out of control, turn into a corporate nightmare and unnecessarily cost the company millions of dollars. During in-depth sessions, attendees will 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.

When Things Go Wrong:
Overcoming Compliance Issues in 483s, Warning Letters and Consent Decrees
**FDAnews Virtual Conference**
Dec. 12, 2014 — 9:00 a.m. – 2:30 p.m. EST
http:// http://www.fdanews.com/OvercomingComplianceIssues

Every drug and device maker dreads the day the FDA investigator will come.

Take a few false steps and a 483 could become a warning letter or even worse, a consent decree.

An oversimplification? Of course.

A real possibility? Yes, this could happen.

Before being at the losing end of a 483, warning letter or consent decree, there's a preemptive course of action to consider. Attend the Dec. 12 FDAnews virtual conference When Things Go Wrong: Overcoming Compliance Issues in 483s, Warning Letters and Consent Decrees.

This virtual conference is designed to help drug and device manufacturers avoid situations in which manageable compliance issues unexpectedly spiral out of control, turn into a corporate nightmare and unnecessarily cost the company millions of dollars.

During in-depth sessions, attendees will 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, attendees will have a keener understanding of the kinds of errors they must avoid, based on other companies documented problems.

Attendees will gain a detailed and clearer understanding of the following:

  •     The progression and severity of the various FDA compliance findings, what triggers should manufacturers 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 manufacturers 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

Meet the Presenter:
Charity Ogunsanya, CEO of Pharmabiodevice Consulting LLC, 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.

Who Will Benefit:

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

Virtual Conference Details:
When Things Go Wrong:
Overcoming Compliance Issues in 483s, Warning Letters and Consent Decrees
**FDAnews Virtual Conference**
Dec. 12, 2014 — 9:00 a.m. – 2:30 p.m. EST
http:// http://www.fdanews.com/OvercomingComplianceIssues

Tuition:
$1.297 per site -- includes virtual conference registration and audio cds and transcripts

Easy Ways to Register:
Online:     http:// http://www.fdanews.com/OvercomingComplianceIssues
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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