The Lifecycle of the Quality Management System: Part 3:
Quality is a universal principle, and this volume delivers essential tools for maintaining the Lifecycle of the Quality Management System, as defined by ICHQ10. Targeted for pharmaceutical companies, it introduces the critical framework, The Lifecycle of the Quality Management System.
This volume includes the highly sought after controlled documents for:
-Batch Record Review
-Batch Disposition
-Process and Production Controls
-Product and Process Lifecycle
-Process & Method Development
-Laboratory Controls
-Specification Management
-Labeling Control
-Facilities and Engineering Management
-Stability
-Qualification and Validation Programs
-BPDR
When executed in compliance with regulations and internal standards, these programs ensure a product is maintained throughout the lifecycle as governed by the QMS.
Whether in pharmaceuticals or beyond, this volume offers a structured, actionable approach to achieving quality excellence across industries.
1147009015
The Lifecycle of the Quality Management System: Part 3:
Quality is a universal principle, and this volume delivers essential tools for maintaining the Lifecycle of the Quality Management System, as defined by ICHQ10. Targeted for pharmaceutical companies, it introduces the critical framework, The Lifecycle of the Quality Management System.
This volume includes the highly sought after controlled documents for:
-Batch Record Review
-Batch Disposition
-Process and Production Controls
-Product and Process Lifecycle
-Process & Method Development
-Laboratory Controls
-Specification Management
-Labeling Control
-Facilities and Engineering Management
-Stability
-Qualification and Validation Programs
-BPDR
When executed in compliance with regulations and internal standards, these programs ensure a product is maintained throughout the lifecycle as governed by the QMS.
Whether in pharmaceuticals or beyond, this volume offers a structured, actionable approach to achieving quality excellence across industries.
199.0 In Stock
The Lifecycle of the Quality Management System: Part 3:

The Lifecycle of the Quality Management System: Part 3:

by Michael A. Delitala
The Lifecycle of the Quality Management System: Part 3:

The Lifecycle of the Quality Management System: Part 3:

by Michael A. Delitala

Hardcover

$199.00 
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Overview

Quality is a universal principle, and this volume delivers essential tools for maintaining the Lifecycle of the Quality Management System, as defined by ICHQ10. Targeted for pharmaceutical companies, it introduces the critical framework, The Lifecycle of the Quality Management System.
This volume includes the highly sought after controlled documents for:
-Batch Record Review
-Batch Disposition
-Process and Production Controls
-Product and Process Lifecycle
-Process & Method Development
-Laboratory Controls
-Specification Management
-Labeling Control
-Facilities and Engineering Management
-Stability
-Qualification and Validation Programs
-BPDR
When executed in compliance with regulations and internal standards, these programs ensure a product is maintained throughout the lifecycle as governed by the QMS.
Whether in pharmaceuticals or beyond, this volume offers a structured, actionable approach to achieving quality excellence across industries.

Product Details

ISBN-13: 9781966029700
Publisher: Collins Publishing House
Publication date: 02/07/2025
Pages: 80
Product dimensions: 8.50(w) x 11.00(h) x 0.25(d)

About the Author

Discover the expertise of Michael A. Delitala, a leader in quality management and compliance with nearly 30 years of experience in the pharmaceutical industry. Holding a Master of Science in Biomedical Laboratory Operations from Michigan State University, he is the owner of Delitala Quality Consulting & Author Corporation. Renowned for his trusted insights, Delitala is not only a seasoned consultant but also an accomplished writer. He excels at breaking down complex concepts into clear, accessible language, making quality principles easy to understand and implement. Whether you’re looking to enhance your organization’s compliance or deepen your knowledge of quality management, Delitala’s passion and expertise can guide you toward success in both your personal and professional endeavors.
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