Online event Learning from FDA Warning Letters

Website https://compliance2go.com/product/?pid=CP2014-373 | Edit Freely

Category Biotechnology ;Medical Device ;Pharmaceutical

Deadline: February 03, 2015 | Date: February 03, 2015

Venue/Country: Online, U.S.A

Updated: 2015-01-27 15:23:09 (GMT+9)

Call For Papers - CFP

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