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How to Implement USP <1058> for Lab Equipment Qualification: Creating a Bullet-Proof Master Plan
Worldwide, USP general chapter <1058> is considered the gold standard for analytical instrument qualification and calibration.
But the large number of FDA warning letters continually issued for improper equipment qualification is a clear sign that companies are still struggling to correctly implement this requirement.
Some say it's because <1058> doesn't really give specific 'how to' advice on qualifying laboratory instruments. Regardless of the reason, though, manufacturers are desperately looking for answers to their questions. There's a real need for help.
That's why FDAnews and Dr. Ludwig Huber, PhD, joined together for How to Implement USP <1058> for Lab Equipment Qualification.
During this webinar CD and transcript, Dr. Huber takes you step-by-step through the complete qualification process and teach you how to create a bullet-proof master plan that will pass FDA scrutiny.
He focuses on the all-important planning process and shows you how to write a practice qualification report. In addition, you'll hear Dr. Huber's practical recommendations and receive such valuable tools as qualification examples, test scripts and templates.
But that's not all. You'll also learn the 3 industry-proven SOPs that take the guesswork out of how you interpret and implement USP <1058>:
BONUS: You'll also get your own downloadable copy of Dr. Huber's 70-page primer “Analytical Instrument Qualification and System Validation," the best reference resource on this topic that you'll find anywhere.
Order today. It's the opportunity of a lifetime to hear directly from Dr. Ludwig Huber, PhD, the recognized expert whose own approach to equipment verification is at the center of this critical FDA requirement.
Ludwig Huber, Ph.D., is the director of Labcompliance and editor of the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems."
More than 20 years ago, Dr. Huber published the 4Q approach for analytical instrument qualification that has been taken for USP <1058>. Since then he has given numerous presentations on GLP/GMP, 21 CFR Part 11 and Validation around the world, including seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, IVT, PDA, PIC/S and other national health care agencies.
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