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Assuring the Effective Use of Standard Operating Procedures (SOPs) In Today's Workforce
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David C. Peterson
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SOPs are written job aids that detail the procedure of how to do a specific job task correctly.
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Navigating Differences Between FDA and EMEA for Regulatory Compliance During Drug Development
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John Simmons
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David Bernstein
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While not yet finalized and adopted, ICH Q10 represents some of the most current thinking with respect to pharmaceuticals manufacturing and control.
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Writing Effective Development Reports
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Paula J. Shadle, PhD
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Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.
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Asset Management for Growing Biotech Companies
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James Erickson
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The challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.
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The Laboratory Control System: Fulfilling cGMP Requirements
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Elizabeth Thomas
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Anita Grochulski
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Ripal Patel
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Sam M. George
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Ling-Zhang
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Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
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Achieving Global Consensus through the International Conference on Harmonization
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Zena G. Kaufman
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Diano Beno
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The concept of design space has started a minor revolution in our industry.
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Expediting the Technical Transfer of Biopharmaceutical Products
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Luz Hermida-Matsumoto
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Anita Grochulski
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Sam George
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Established, fully validated methodology and SOPs are required prior to initiation of any training activities.
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