Actual Construction and Operation of PV Systems/Processes Following a Process Approach - <ebook + Printed Version>
In EU pharmacovigilance operations, the establishment of a quality system based on Module I is mandatory; however, many organizations still lack sufficient implementation and development of such systems. This document explains the fundamental understanding of ISO 9001 and Module I, as well as the actual process construction and operation, audits, and CAPA responses, based on a process approach! It is a recommended read for everyone involved in global PV operations. ■ Key points of this document: 【1】 The explanation is structured along the flow of practical work, making it easy for beginners to understand! Written by an author with many years of experience in PV operations and training at major pharmaceutical companies, this is a textbook on quality systems in PV. 【2】 It complements deficiencies using ISO 9001, which is consistent with Module I. 【3】 PV audits and CAPA responses: ■ In PV audits conducted by organizations independent of the PV department, it is required to possess the capability to evaluate the effectiveness and performance of the system and processes. ■ In reality, there are still many cases where there are issues with root cause analysis, impact assessment, and the content of CAPA.
Inquire About This Product
basic information
■Author Takamitsu Shibuya ■Table of Contents Chapter 1 Overview of ISO 9001 and Module I 1. ISO Standards 2. Overview of ISO 9001 3. Overview of Module I 4. Comparison of ISO 9001:2008 and Module I 5. Documentation and Record Keeping 6. Management Review Chapter 2 Building a PV Business Management System and Quality System 1. Mission, Products, Customers, Stakeholders, Environmental Trends 2. Quality Policy, Quality Objectives 3. Process Development 4. Operation of Systems and Processes 5. Audits 6. Improvement (Addressing Abnormalities and Issues as well as Unfavorable Situations: CAPA)
Price range
Delivery Time
Applications/Examples of results
Please refer to the catalog for details.
catalog（1）
Download All Catalogs
Company information
Nowadays, information is accessible to anyone. However, it is also true that there are barriers that cannot be easily overcome, such as social status based on age, industry, government, company, position, personal connections, and geography, when it comes to acquiring what one truly desires. On the other hand, there is also a barrier where valuable information exists but cannot be communicated to those who need it. Our company aims to transcend that "wall" on behalf of everyone and provide information that connects those in need with those who can share it. 1. We provide a platform for those involved in research and technology at companies to exchange information and foster improvements and advancements in science and practical technology. 2. We offer lectures from corporate engineers and practitioners to undergraduate and graduate students in science and engineering, nurturing the next generation of young talent. 3. We provide children with books that showcase the excitement of science, technology, and the lives and work of those involved in these fields, broadening their future dreams.