Learn 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 attend
FDA 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 Seminar
Current FDA expectations and enforcement related to management reviews
What the investigator will ask for vs. what to provide – and what not to
How to define a review that will meet the requirements of FDA, EMA and other regulatory health agency expectations
Six key challenges to overcome
Four elements of an effective quality systems management review
How to avoid going overboard and still minimize risk
How to structure the review to maximize time and results
Twelve (12) steps to consistently prepare for, conduct, and document effective management reviews
Who will benefit
Quality managers and professionals
Regulatory affairs managers and professionals
Directors of quality and compliance
Vice-presidents of quality, regulatory affairs and compliance
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
10777 Westheimer Suite 1100, Houston, Texas, USA, 77042
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