A Survey of Microbiology for the Pharmaceutical, Biotechnology, and Medical Device Industries
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An Introduction to Food Manufacturing Operations
In Conjunction with Wiley-Blackwell
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An Overview of Documentation Requirements in FDA Regulated Industries
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Critical Limits, Monitoring and Corrective Actions–A HACCP Review
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Dry Food Manufacturing Operations
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Effectively Managing CROs
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Environmental Monitoring for Non-Sterile Drugs
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FDA Quarterly Briefing–April 2009
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FDA Quarterly Briefing–July 2009
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FDA Quarterly Briefing–October 2009
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Food Manufacturing Layout and Design
In Conjunction with Wiley-Blackwell
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Food Safety and Regulations
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History, Theory, and Instrumentation of Near-Infrared Spectroscopy
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Implementing GEP (Good Engineering Practices) in the Pharmaceutical, Bio-Pharmaceutical, and Medical Device Industries
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Instrumental Methods for Pharmaceutical Trace Metals Analysis
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Introduction to cGMP System-Based Audits
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Key PAT Concepts: Focus on Desired State
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Keys to Risk Management: Implementation, Documentation, Monitoring and Mitigation
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Managing Multiple Projects Utilizing Lean Manufacturing Techniques
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Microbial Challenge and Shelf Life Testing for Foods
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PAI: Surviving the Pre-Approval Inspection
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Pharmaceutical Process Validation Basics
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Pharmaceutical Water Systems: Validation and Start-Up
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Protecting the Food Supply from Terrorists: What the Food Industry Needs to Know
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Quality Control and Flavor Usage in Foods
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Refrigerated and Frozen Food Operations
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Selecting a Drug Product Candidate Using Quality Risk Management: PAT & QbD
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Tactics to an Effective FDA Submission
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Thermal Process Operations
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