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| How to Build and Maintain an Effective Pharmaceutical Quality Management System, 1st Edition |
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※해외주문 도서 안내 :
- 해외 및 국내 입고 사항에 따라 2~8주 이상 소요될 수 있으며. 취소 및 반품이 불가능합니다.
- 해외주문도서는 해외 출판사 사정에 의해 품절/지연될수 있습니다. |
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※교환 및 반품안내 :
- 교환이나 반품시 상품 수령후 3일이내 교환이나 반품 의사를 알려주시고 일주일이내에 저희쪽으로 상품이 입고되어야합니다.
시일이 경과되면 반품이 불가합니다.
- 변심에 의한 교환이나 반품시, 배송비는 고객님께서 부담하시며, 오배송이나 상품 불량시에는 무료 교환이 가능합니다.
- 반품시에는 반품상품 검수후 카드 취소를 해드리거나 통장,적립금등으로 환불 조치 해 드립니다. |
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※배송안내 :
- 제주도및 도서산간지역은 택배비가 추가될수 있습니다. |
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Description
How to Build and Maintain an Effective Pharmaceutical Quality Management System shares unique insights on how to improve our understanding of the human factors regarding pharmaceutical quality. It describes practical ways to improve systems thinking and ways to establish effective quality management systems. Insights are derived from the author’s experience at the US Federal Drug Administration (FDA), and as a leader of the FDA’s PAT and 21st Century Initiatives, and finally, as an industry executive. The book describes the fundamental concepts and explains how to improve understanding of QMS, particularly focusing on the essential role of human factors using real-life examples.
Key Features
•Utilizes explicit case studies to illustrate ideas throughout the content
•Emphasizes three key areas, including management, supervisors and staff
•Written by a leader in the field with experience in regulatory, research and technical areas
Readership
Pharmaceutical professionals in manufacturing, quality and regulations, from technicians to senior management. Will be of interest to advanced graduate students and post-docs
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Section I: Why is pharmaceutical quality assurance prone to frequent failures?
1. Introduction to pharmaceutical quality in the context of therapeutic outcomes
2. Pharmaceutical quality failures in the 20th century
3. Progress and challenges in moving towards the desired state of pharmaceutical quality in the 21st century
4. Human factors, biases, and blind-spots and science and technology gaps
Section II: What is the 21st Century Pharmaceutical Quality?
5. A new, higher, level of quality assurance
6. 21st pharmaceutical quality, 21st Cures Act & Manufacturing USA
7. Case Example: QMS Considerations for successful launch of a complex generic product
Section III: How to build and maintain an effective Pharmaceutical QMS
8. Remediating an existing QMS: After negative regulatory outcome
9. Effectiveness Assessment of an Existing QMS: Preventing a negative regulatory outcome
10. Ceasing dependence on external regulators: Culture of Quality |
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등록된 서평이 없습니다. |
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과별도서목록
