SKU: 85311013355

GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates

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Description

GMP Compliance at Validation, Qualification & Documentation with practical case studies and templatesThis book offers understandable introductions to the GMP technical basics and concepts for validation & qualification of projects in the areas of Pharma Biotech ATMP Medical Device. The necessary specialist knowledge about GMP guidelines (validation qualification documentation) was made easily and understandably accessible via example and simulated projects. Topics in this book are: What is qualification, and what is validation? Why am I qualifying?

This book offers understandable introductions to the GMP technical basics and concepts for validation & qualification of projects in the areas of Pharma / Biotech / ATMP / Medical Device.
The necessary specialist knowledge about GMP guidelines (validation/qualification/documentation) was made easily and understandably accessible via example and simulated projects.
Topics in this book are:
¥ What is qualification, and what is validation?
¥ Why am I qualifying?
¥ How do I start with a GMP concept/project? ¥
What are my GMP qualification strategies?
¥ How do I write a project risk analysis?
¥ What is change control (CC) and do I need a master or sub CC?
¥ How do I write a Validation Master Plan (VMP)?
¥ What is an FMEA, and why do I need an FMEA?
¥ How do I write an FMEA?
¥ How do I write a qualification plan (QP)?
¥ What are FAT & SAT? And do I need these tests?
¥ How do I create qualification documents (DQ, IQ, OQ, PQ)?
¥ Step-by-step validation and qualification using case studies

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SKU: 85311013355

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Bozeman, US
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Pretty
Color: Gray
The Tray is exactly like the picture ..It pretty and sturdy .The material is great.
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Whiting, US
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A Stylish and Functional Addition to My Décor!
Color: Gray 1 Pack, Size: 8" x 8" x 1.8", Color: Gray 1 Pack, Size: 8" x 8" x 1.8"
I recently purchased the ZHEM Valet Tray for Men in Dark Gray, and I couldn't be happier with this product. It's become an indispensable part of my daily routine and home décor. The design and craftsmanship of this tray are outstanding. The dark gray color is elegant and complements my furniture perfectly. It's not just a valet tray; it's also a decorative piece that adds a touch of sophistication to my nightstand and dresser. The size (8x8x1.75 inches) is ideal for holding my daily essentials like my watch, perfume, keys, and even napkins. I appreciate the versatility - it serves as a decorative piece, an organizer, and a functional tray all in one! The quality is top-notch, and it feels sturdy and well-made. It's also easy to clean, which is a big plus. Overall, the Tray has exceeded my expectations. It's a stylish and functional addition to my décor, and I highly recommend it to anyone looking for a versatile and attractive tray for their home. Five stars! ⭐⭐⭐⭐⭐
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Super cute landing space for keys
Color: White 1 Pack, Size: 8" x 8" x 1.8", Color: White 1 Pack, Size: 8" x 8" x 1.8"
I always have trouble finding my keys and so it’s been very helpful to have a dedicated spot to easily throw them in when I get home. At first I thought it would be too big but it’s the perfect size for two wallets and keys, and it’s good quality albeit a bit expensive. The gold isn’t too shiny either, it’s a nice touch and it really reduces the look of clutter on your surfaces and helps it look more organized. It also doesn’t slip around.
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Using it in the coffee table for remote contrls and headphone. Keeps organized and looks good. Perfect size.
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Very nice! It organized stuff in my moms room to look more put together.
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