£88.72

Validating Artificial Intelligence Frameworks in GxP Environments: A Practitioner's Handbook

Other Branches of Medicine

Price data last checked 53 day(s) ago - refreshing...

View at Amazon

We'll watch every seller, every day. One email when your price arrives.

This is the most expensive it has ever been. Walk away.

£89 today · previous high £89 · all-time low £75

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↓ Price chart
when this has been cheap or pricey

↓ Forecast
where the price is heading next

↓ Statistics
all-time high & low, recent range

↑ Price alert
name your number, we'll email you

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 14 days · 14 data points (no recent data)

Historical

Generating forecast…

Price Distribution

Price distribution over 14 days • 2 price levels

Days at Price

Current Price

Price Analysis

Most common price: £75 (13 days, 92.9%)

Price range: £75 - £89

Price levels: 2 different prices over 14 days

Description

Your AI model is already making GxP decisions. Can you prove it should? Machine learning has walked straight onto the manufacturing floor, and the first GMP enforcement actions naming AI are already on the record. The old comfort question, "is the software installed correctly," won't save you now. Inspectors want to see that a model does what you claim, holds its nerve as the data shifts under it, and leaves a trail they can follow line by line. Most quality systems can't show that yet. This book teaches you how. This is the playbook. It bolts a disciplined AI layer onto the CSV and CSA foundation you already run, puts risk in charge of every decision instead of paperwork, and walks one real system from intended use all the way to inspection-ready evidence. No theory dumps, no hand-waving, a method you can put to work Monday morning. What you get: A four-tier risk model that tells you exactly how hard to validate, so you stop gold-plating the trivial and stop gambling on the dangerous IQ, OQ and PQ rebuilt for both static and self-learning AI 28 ready-to-run templates and a complete AI Validation Master Plan Data drift, retraining governance and decision integrity, made practical and defensible A draft Annex 22 crosswalk, a 120-question inspection bank, and a fully worked evidence pack Written for QA and Quality leaders, IT compliance practitioners, regulatory peers, and the executives who sign off on the risk. Grounded in ICH Q9, EU Annex 11, 21 CFR Part 11, FDA Computer Software Assurance, the EU AI Act, and the draft Annex 22. Sachin Bhandari has spent more than 25 years in pharmaceutical Quality IT and validation, and has carried AI-supported quality systems through health-authority inspection with zero compliance findings. AI has already reached your GxP floor. This is how you stay in control of it.

Product Specifications

Format: paperback
ASIN: 935914651X
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Other Branches of Medicine
Domain: Amazon UK
Release Date: 15 June 2026
Listed Since: 17 June 2026

Barcode

No barcode data available

Validating Artificial Intelligence Frameworks in GxP Environments: A Practitioner's Handbook

This is the most expensive it has ever been. Walk away.

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

The Regulatory Affairs AI Playbook: How RA Professionals Run FDA, EMA & PMDA Submissions with GMLP-Compliant AI and 21 CFR Part 11 Validation

Enterprise AI Compliance: The Risk and Governance Handbook — Frameworks, Audit Controls, and Accountability Structures for Regulated Industries, EU AI Act, NIST AI RMF, and Global Mandates

ISO 42001 for UK Healthcare: A Practical Guide to AI Governance, Assurance and Accreditation

AI and the Boardroom: Insights into Governance, Strategy, and the Responsible Adoption of AI

Architectures for the Intelligent AI-Ready Enterprise: Building real-world solutions with MongoDB

Decision-Quality AI: From AI Ambition to Operational Success

The GxP Data Integrity Audit-Ready Manual: ALCOA++ Implementation Frameworks, Audit Trail Review Programs, Electronic Record Controls, and ... and Life-Science Quality Operations

Revolutionizing the Healthcare Sector with AI

AI-Driven Diagnostics for 6G-Enabled Smart Healthcare

Source Book in Artificial Intelligence

Determann’s Field Guide to Artificial Intelligence Law: International Corporate Compliance (Elgar Compliance Guides)

Practical Process Validation

The Hybrid Mind: The Human-AI Convergence

Explainable AI for Transparent and Trustworthy Medical Decision Support

Embedded Artificial Intelligence and the Internet of Things for Photovoltaic Systems: From Monitoring to Maintenance and Security

The Evolution of Artificial Intelligence in Healthcare: From Basic Methods to Clinical Practice

AI in Healthcare: How Artificial Intelligence Is Changing IT Operations and Infrastructure Services

Artificial Intelligence Techniques for Analysing Sensitive Data in Medical Cyber-Physical Systems: System Protection and Data Analysis: 12 ... Systems and Critical Infrastructures, 12)

The Cybersecurity Trinity: Artificial Intelligence, Automation, and Active Cyber Defense

The Clinical AI Governance Implementation Handbook: NIST AI RMF Aligned Workflows, Model Risk Registers, Bias Testing Protocols, ePHI Data Governance ... for Health-System AI Governance Committees

Self-Learning AI in Healthcare: Agentic Systems for Smarter Medicine

Data Validation A Complete Guide

Artificial Intelligence in Point-of-Care Nanobiosensors Technology: Enhancing Disease Diagnostics and Improved Healthcare Outcomes

Applied AI Security: From Models to Agents