Book: The Essence of Risk Management in Pharmaceutical Manufacturing and Case Studies of Its Application
Challenges in Implementing Risk Management at Manufacturing Sites and Examples of Risk Assessment - Specifically, how should we confront risks?
This book explains and presents case studies based on the authors' experiences regarding approaches to risk. Please use the cases introduced here as a reference to prevent omissions in risk when implementing them in your own company. # Points raised in inspections related to risk management # Are you unsure about how to specifically confront risks? # Have you been conducting risk assessments until now? # Understanding of risk, sharing within the company, and the quality of risk assessments.
Inquire About This Product
basic information
■Editors Katsuharu Miyajima, NanoCarrier Co., Ltd. ■Authors Yukio Hiyama, National Institute of Health Sciences Yoshimura Maeda, NanoCarrier Co., Ltd. Nobuyuki Isshiki, Kissei Pharmaceutical Co., Ltd. Akihito Yasuda, Nippon Shinyaku Co., Ltd. Yukie Matsumura, Quality Management Advisor [Formerly Eisai Co., Ltd.] Tadayuki Takashima, Filler Systems Co., Ltd. [Formerly Astellas Pharma Inc.] ■Table of Contents Chapter 1: The Importance of Risk Management in Drug Development and Manufacturing Chapter 2: Basics of Risk Management Chapter 3: Key Points for Creating Risk Management SOPs Chapter 4: Risk Management and Process Validation Chapter 5: Fundamental Concepts of Risk Communication and Risk Review Chapter 6: Specific Examples of Risk Assessment in Pharmaceutical Factories Section 1: Case Studies of Risk Evaluation in Pharmaceutical Manufacturing Sites Section 2: Case Studies of Risk Evaluation in the Research and Development Stage for Production Transfer Chapter 7: Corrective and Preventive Action Systems and Quality Risk Management - Using Deviation Handling as an Example - Chapter 8: Inspections and Risk Management
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.
![Basic Knowledge Related to Teams and Organizations [4 Themes in Total]](https://image.mono.ipros.com/public/product/image/475/2000874897/IPROS05672210813334317907.jpeg?w=280&h=280)
![On-site Improvement and Work Analysis Helpful Materials [Nao Sasaki's Improvement Column]](https://image.mono.ipros.com/public/product/image/720/2000613979/IPROS10933623742376703553.png?w=280&h=280)
