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Special Edition: A Roadmap to GMP Compliance Part 1
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Item Number: IVTZGMP1
Compiled from articles published by the Journal of Validation Technology and Journal of GXP Compliance, this resource guide presents the various techniques and methods used by quality and compliance professionals in their daily work responsibilities for use as practical work applications.
Articles include:
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GMP Failures: Ignorance or Arrogance?
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Implementing the Tools of Process Quality - A Policy Statement
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Data Culture
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An Example of Absence of a Data Culture
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Upsizing Compliance in a Downsizing Environment: Strategies for Ensuring GXP Compliance in the Face of Cost Reductions
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Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I - The Role of Human Heuristics
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Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part II - Risk Communication and Perception Issues
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GXP Excellence by Design (XbD): Applying the Principles of Excellence to the GXP Environment
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Review of Batch Production Records
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GMP Yield - Considerations Beyond Percent Theoretical Yield
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Substandard Data and Documentation Practices - Case Study #9
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Effective Personnel Qualification - Does the Job Description Play a Role in CGMP Compliance?
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Reader Q&A - Q#36 Deviations and Exceptions in Validation Q#37 WFI Sampling and Testing
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Reader Q&A - Q#32 FDA Audits Q#33 PAT
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Reader Q&A - Q#28 QA ROI Q#29 ISO and ICH Q10
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Reader Q&A - Q#26 Prototypes for Clinicals Q#27 Packaging Testing
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Reader Q&A - Q#40 What is a complaint? Q#41 Documentation for Raw Material Inspections
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List Price: $590.00
Price: $501.50
You Save: $88.50 (15 %)
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