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Pharmaceutical Engineering Archives |
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January/February 1998| Design/Build Project Delivery Method: Strategic Opportunities for Pharmaceutical Facilities by Andrew A. Signore, PE Design/Build method offers clean advantages to pharmaceutical industry competitiveness.  Download Article... |
Baseline™ Pharmaceutical Engineering Guides - An Update by Pamela A. Jones & Sion Wyn An update on the Baseline™ guide development including a review of the validation implications thus far. Download Article... |
Integrated Validation: A Way of Streamlining Projects to Reduce Project Validation Time and Cost by Phil James, PhD This article proposes some practical suggestions for streamlining the process of validation up to and including OQ. Download Article... |
Pharmaceutical Engineering Interviews Dr. Kurt Hausmann, the Head of Global Technical Operations and Manufacturing for Hoffmann-La Roche by Dr. Kurt Hausmann Pharmaceutical Engineering Interviews Dr. Kurt Hausmann, the Head of Global Technical Operations and Manufacturing for Hoffmann-La Roche Download Article... |
New FDA Regulations Using Computer Technology by Christie Deitz, James Nelson & Joanne Salazar This article describes the new FDA regulation on electronic signatures and records, the use of current technologies and standards to create an electronic batch record, and the benefits that can be realized. Download Article... |
Monitoring and Control of the Lyophilization Process Using a Mass Flow Controller by David R. Chase This article presents an alternative method for monitoring and controlling the lyophilization process. Download Article... |
Validation and Commissioning by Louis A. Angelucci, III This article describes validation and commissioning working together for a better fit and stresses the importance of qualification and the audit function that validation has. Download Article... |
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