Compliance Gurus Inc Company And Services
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19-Oct-2014 -
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Transcript of Compliance Gurus Inc Company And Services
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Company Information & Services
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Company• Founded in 2003
• Supports the following industries:
• Biological, Cosmetic, Drug, Device, Dietary Supplements, Food
• Consulting Services
• Software Division
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Services• Internal Auditing
• SOPs, Work Instructions, & Policies
• Computer System Validation Documentation
• Manufacturing Documentation
• Laboratory Documentation
• Clinical Documentation
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Services• External Auditing
• Software & Hardware Vendors
• Raw Material & API Suppliers
• Drug Product Component Suppliers
• CROs & CMOs
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Services• Computer System Validation
• Manufacturing & Laboratory Systems
• Pre-Clinical & Clinical Systems
• Business Systems
• Warehouse Management Systems
• ERP & MRP Systems
• Network Qualification
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Services
• Equipment and Process Validation
• Existing Equipment
• New Equipment
• Plant Startups
• Commercial Process Validation
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Services
• Compliance Assessment & Report
• Pre-Clinical & Clinical
• Laboratory & Manufacturing
• Warehouse
• Compliance Assessment Report
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Services
• Quality System Implementation
• New
• Assess & Update Existing
• Reasonable Approach
• Functional
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Services
• Project Management
• Manage Projects
• Portfolio Management
• Portfolio Analysis
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Services
• Remedial Compliance Consulting
• EIRs
• 483s
• Warning Letters
• Untitled Letters
• Consent Decree
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Services
• Training
• Auditing
• GCP, GLP, & GMP
• Computer System Validation
• 21 CFR Part 11
• FDA Awareness
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Services
• Software Division
• Software Development
• Web Development
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Gregor Library
• FDA Documents
• 483s, EIRs, NDAs, Responses, Warning Letters and much more...
• http://gregorlibrary.com/