Live event Learning from FDA Warning Letters
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Website https://compliance2go.com/product/?pid=CP2014-373 |
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Category Biotechnology ; Medical Device ; Pharmaceutical
Deadline: February 02, 2015 | Date: February 03, 2015
Venue/Country: Online, U.S.A
Updated: 2015-01-23 17:32:52 (GMT+9)
Call For Papers - CFP
DESCRIPTIONLearn 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 attendFDA 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 SeminarCurrent FDA warning letter trendsUnderstanding the warning letter process ? from inspection to enforcementOther enforcement tactics used by the agency instead of a warning letter ? and why you’ll never see themHow to analyze a warning letter ? code phrases, prioritization points, and moreHow to “read between the lines” of a warning letterHow to share warning letters in a way that’s immediately relevant and actionableReview current FDA inspectional emphases in warning lettersHow to use warning letters to anticipate inspectional priorities at your firmOther ways to use public warning letters, from supplier qualification, training tool, and moreWho will benefitQuality managers and professionalsRegulatory affairs managers and professionalsDirectors of quality and complianceWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationAttendance of Certificate
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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