Handbook of Validation in Pharmaceutical Processes, Fourth Edition: Edition 4
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Key Features:
- Provides an in-depth discussion of recent advances in sterilization
- Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
- Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
- New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
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James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. He was previously Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP’s Microbiology and Sterility Assurance Expert Committee for 2005-2015. He is a frequent author and lecturer on sterilization, aseptic processing and process validation.
