This webinar explains the issues and techniques that regulators may use when investigating your water systems for "GMP flaws". More than likely, even the most quality-conscious organization has some water system "skeletons" in their closets, perhaps unwittingly. These "skeletons" or deficiencies are often connected with the site’s Quality Systems and are indicative of your Quality Systems health, so having an uneventful water system audit (which would be facilitated by attending this webinar and proactively addressing the issues presented therein) could keep the regulators out of other typically fertile territory for regulatory deficiencies found elsewhere at your site.
Why should you attend:
Ever wonder how the regulatory inspectors manage to hone in on the very water system problems you were hoping they wouldn’t notice? It’s actually not hard - they are trained either by classes or OJT, and it is not rocket science either. And why do they tend to pick on water systems? The answers are in this webinar. Water system design, operations, sampling, and testing data are rife with common but unwittingly bad practices that are linked to every element of your Quality Systems. You will learn how the inspectors can find the hidden flaws so quickly in this webinar that was originally created as a training module for a foreign inspectorate for quickly finding deficiencies in any water system.
By attending, you can put yourself in the interrogation room and hear the questions they may ask, and see why they look for certain things and ask for certain documents. You will realize why your routine water system operations, investigations and other documentation, and your answers can lead them on that "fishing expedition" that directs them to all the "fishing holes" in your entire Quality Systems Program. Prepare yourself for the inevitable water system inspection so you are not caught with avoidable deficiencies, deficiencies that could seriously compromise the outcome of a Quality Systems Inspection and its adulterative impact on your products.
Areas Covered in the Session:
How Initial Deficiencies Lead to Others
Design and Construction Issues
Source Water Issues
Change Control Issues
Excursion Investigation Issues
Who Will Benefit:
Validation managers and personnel
QA managers and other personnel involved in Change Control programs
Utility operators and their managers involved in maintaining and sanitizing water systems
QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
QA managers and personnel involved in investigations of excursions and preparing CAPAs
QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
Event Link - http://bit.ly/QyGycT