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Quality Operations Procedures for Pharmaceutical, API, and Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif
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- Sales Rank: #3657520 in Books
- Brand: Brand: CRC Press
- Published on: 2012-06-06
- Original language: English
- Number of items: 1
- Dimensions: 10.25" h x 7.00" w x 1.25" l, 2.65 pounds
- Binding: Hardcover
- 584 pages
- Used Book in Good Condition
About the Author
Syed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and in-process control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars comparative studies, organizing preclinical studies, and preparation of the Central Technical Dossier (CTD) formatted for regulatory submission. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development.
Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has worked in US FDA- and Health Canada–approved facilities in managerial positions under the quality operations umbrella. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.
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