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Modeling Human Behavior

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Application of Systems Engineering in Project Management: Modeling With Metrics

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FDA Regulations:

21 CFR Part 211 cGMP’s for Drug Products

• General Provisions
• Organization and Personnel
• Buildings and Facilities
• Equipment
• Control of Components and Drug Product Containers and Closures
• Production and Process Controls
• Packaging and Labeling Control
• Holding and Distribution
• Laboratory Controls
• Records and Reports
• Returned and Salvaged Drug Products

21 CFR Part 610 cGMP’s for biologics

• Release Requirements
• General Provisions
• Standard Preparations and Limits of Potency
• Mycoplasma
• Testing Requirements for Communicable Disease Agents
• Dating Period Limitations
• Labeling Standards

21 CFR Part 58 cGMP’s for Good Laboratory Practice for Nonclinical Laboratory Studies

• General Provisions
• Organization and Personnel
• Facilities
• Equipment
• Testing Facilities Operation
• Test and Control Articles
• Protocol for and Conduct of a Nonclinical Laboratory Study
• Records and Reports
• Disqualification of Testing Facilities

INCOSE

International Council on Systems Engineering – INCOSE

Chicagoland Chapter – INCOSE   

Chicagoland Chapter Calendar – 2013

"Pitfalls of FMEAs" - Chicagoland Chapter - INCOSE