Live Online Training Conducting an Effective Quality System Management Review
View: 213
Website https://compliance2go.com/product/?pid=CP2014-370 |
Edit Freely
Category Biotechnology , Medical Device , Pharmaceutical
Deadline: December 02, 2014 | Date: December 02, 2014
Venue/Country: Houston, U.S.A
Updated: 2014-11-21 16:32:25 (GMT+9)
Call For Papers - CFP
DESCRIPTIONLearn how FDA expects to see how you plan, prepare for, conduct, and follow-up on your quality system management review. See the records you can show FDA. Understand how to translate quality system management review outcomes to business actions.Why you should attendFDA requires management to hold regular quality systems reviews ? and use the results to ensure the continuing effectiveness and suitability of the quality system and FDA compliance. But even the most recent FDA guidance documents do not discuss what should go into a management review. And yet, every month seems to bring another FDA warning letter citing poor management reviews and controls. Do you know what to put in your quality system review…and what not to? 2008-2012 saw a two-fold rise in disgruntled investor lawsuits alleging unnecessary delay of product market launches due to noncompliant quality systems. Even failure to properly address FDA-483s in management disclosures can be grounds for an investor lawsuit. To make the most of your efforts and minimize your risks, you need to structure your quality systems management review so that it proves FDA compliance and demonstrates effective executive involvement and oversight of your quality system.This webinar is intended for quality management personnel of FDA-regulated companies. Attendees will receive practical and easy-to-use information that converts warning letter cautions, FDA official statements, and investigator questions into real-world processes and valuable benefits. So if you don’t want to receive a Warning Letter from FDA citing you for poor management control, learn how to plan, run and follow-up from an effective, compliance quality system management review.Areas Covered In the SeminarCurrent FDA expectations and enforcement related to management reviewsWhat the investigator will ask for vs. what to provide ? and what not toHow to define a review that will meet the requirements of FDA, EMA and other regulatory health agency expectationsSix key challenges to overcomeFour elements of an effective quality systems management reviewHow to avoid going overboard and still minimize riskHow to structure the review to maximize time and resultsTwelve (12) steps to consistently prepare for, conduct, and document effective management reviewsWho will benefitQuality managers and professionalsRegulatory affairs managers and professionalsDirectors of quality and complianceVice-presidents of quality, regulatory affairs and complianceWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.