(EBook PDF) Laboratory Control System Operations in a GMP Environment 1st edition by David Bliesner 1119529298 9781119529293 full chapters

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Product details:

ISBN-10 :  1119529298 

ISBN-13 : 9781119529293

Author: David M. Bliesner 

The Guide is written for a broad audience; it is applicable to both Quality Control and Quality Assurance professionals in small, medium and large companies within the pharmaceutical and biopharmaceutical industries. R&D personnel working in non-GMP environments will also benefit applying the organizational schemes and principals presented in this text. Also, foreign firms in China and India will find this book especially useful.

Readers typically have the following titles: Laboratory Support Technician, Laboratory Quality Assurance Reviewer and Auditor, Analytical Laboratory Group Leader, Laboratory Quality Control Technician, Analytical Methods Validation Technician, Analytical Laboratory Manager, Laboratory Quality Assurance Manager, Site Management

 

Laboratory Control System Operations in a GMP Environment 1st Table of contents:

1 Introduction to the Quality Systems Based Approach to CGMP Compliance
Overview of Quality Systems and the Laboratory Control System
Regulations and Regulatory Bodies
Regulatory Guidance
Application of This Text
Overlap and Redundancy
Tools and Templates
References
Note
2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)
Description of the Laboratory Managerial and Administrative Systems Sub Element
Contents of the Sub Element
Tools and Templates
Reference
3 Components of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element (OP)
Description of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element
Contents of the Sub Element
Tools and Templates
4 Components of the Laboratory Equipment Sub Element (LE)
Description of the Laboratory Equipment Sub Element
Contents of the Sub Element
Tools and Templates
References
5 Components of the Laboratory Facilities Sub Element (LF)
Description of the Laboratory Facilities Sub Element
Contents of the Sub Element
Tools and Templates
References
6 Components of the Method Validation and Method Transfer Sub Element (MV)
Description of the Method Validation and Method Transfer Sub Element
Contents of the Sub Element
Tools and Templates
Glossary
References
7 Components of the Laboratory Computer Systems Sub Element (LC)
Description of the Laboratory Computer Systems Sub Element
Contents of the Sub Element
Tools and Templates
Glossary
References
8 Components of the Laboratory Investigations Sub Element (LI)
Background and Regulatory History of Out-of-Specification Investigations
Description of the Laboratory Investigations Sub Element
Contents of the Sub Element
Common Problems Related to Laboratory OOS Investigations
Tools and Templates
Glossary
References
9 Components of the Laboratory Data Governance and Data Integrity Sub Element (DI)
Background
Precepts Regarding Data Governance and Data Integrity
Description of the Laboratory Data Governance and Data Integrity Sub Element
Contents of the Sub Element
Tools and Templates
Glossary
References
Further Reading
10 Components of the Stability Program Sub Element (SB)
Description of the Stability Program Sub Element
Contents of the Sub Element
Model Standard Operating Procedures for Establishing and Maintaining a Stability Program
Tools and Templates
Glossary
References
Note
11 Components of the General Laboratory Compliance Practices Sub Element (CP)
Description of the General Laboratory Compliance Practices Sub Element
Contents of the Sub Element
Tools and Templates
12 Summary for Establishing and Maintaining a Laboratory Control System
A Brief Review of the Laboratory Control System and Its Sub Elements
How Things Can Go Wrong: Examples of Some Regulatory Citations Organized by Sub Element
Some Final Thoughts on Establishing and Maintaining a Compliance Laboratory Control System

 

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