Books + eBook: Implementation Procedures for Technology Transfer (Testing Methods and Manufacturing Processes) and Ensuring Equivalence
Challenges in Pharmaceutical Quality Systems and Management Strategies Based on QbD Approach/Q12 and EC
【Book + eBook】 For details and applications for this product, please check our website. https://www.science-t.com/ebook/EB029a.html The highly acclaimed book is now available in digital format! Downloadable on up to 10 devices. ~Set version of Book + eBook~ A technical specialty book that can be read on smartphones and tablets during overseas business trips, commutes, or meetings, designed for multiple users*【eBook (electronic book)】 *5 accounts: Up to 2 devices per account *This product is a set version of the book + eBook. ~Science & Technology eBook (electronic book)~ ✔ Once downloaded, it can be viewed offline, making it accessible even while overseas or on business trips. ✔ Since up to 2 devices can be downloaded per person, you can view it on both your work PC and personal tablet by downloading the app. ✔ It can be viewed by up to 5 people (5 accounts), allowing for sharing within departments. ✔ If you change your PC, you can re-download it from the web page.
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■Supervision Yukio Hiyama, National Institute of Health Sciences ■Authors Akio Imai, Eisai Co., Ltd. Osamu Hiruta, Meiji Seika Pharma Co., Ltd. Tomonori Nakagawa, Otsuka Pharmaceutical Co., Ltd. Mitsuhisa Yamano, Spira Pharma Co., Ltd. Makoto Yokoyama, Eisai Co., Ltd. Yuji Okada, Eisai Co., Ltd. Akiyoshi Kamiya, former Pfizer Inc. Ryoaki Orii, Astellas Pharma Inc. Kazunari Kio, Astellas Pharma Inc. Motoyoshi Okamura, Pharmatree Co., Ltd. ■Table of Contents Introduction: Ensuring Quality Consistency in Technology Transfer Part 1: Challenges in Business Systems (Pharmaceutical Quality Systems) in Technology Transfer and the QbD Approach Part 2: Case Studies/Responses by Type of Technology Transfer - Ensuring Equivalence and Response Cases in Manufacturing/Testing Method Technology Transfer Part 3: Technology Transfer in Biopharmaceuticals and CMO Outsourcing
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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.
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