2015 - Learning from FDA Warning Letters

DESCRIPTION
Learn how to use FDA warning letters to other firms to improve your compliance, from analyzing the meaning behind key phrases in warning letters to teasing out specific FDA expectations of SOP elements and risk-based priorities. Understand how to translate FDA warning letters into effective guidance for your company to avoid public embarrassment, financial loss, and litigation.
Why you should attend
FDA warning letters are a powerful compliance tool. Properly analyzed, warning letters are just as helpful as guidance documents and FDA speeches. A warning letter provides direct, immediate insight into the agency’s rule interpretations and daily expectations.Increasingly, FDA warning letters are being scrutinized by investors and analysts, as well as savvy business partners and potential suppliers contemplating long-term business relationships with your firm. This year, US courts ruled that failure to disclose even one FDA-483 observation, much less a series of 483s that can lead to a warning letter, is grounds for an investor lawsuit.If you can learn and apply the lessons from warning letters, you can turn a public enforcement action into a competitive edge.
This webinar is intended for quality, regulatory and compliance personnel of FDA-regulated companies. Attendees will receive practical, time-tested advice on how to translate any warning letter into concrete action and regulatory intelligence.
Areas Covered In the Seminar
Current FDA warning letter trends
Understanding the warning letter process ? from inspection to enforcement
Other enforcement tactics used by the agency instead of a warning letter ? and why you’ll never see them
How to analyze a warning letter ? code phrases, prioritization points, and more
How to “read between the lines” of a warning letter
How to share warning letters in a way that’s immediately relevant and actionable
Review current FDA inspectional emphases in warning letters
How to use warning letters to anticipate inspectional priorities at your firm
Other ways to use public warning letters, from supplier qualification, training tool, and more
Who will benefit
Quality managers and professionals
Regulatory affairs managers and professionals
Directors of quality and compliance
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Attendance of Certificate