Regulatory & Compliance
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Regulated Clinical Documentation And Content – Purpose, Proper Handling, And MetadataDaniel Orfe, Betsy FallenOn-Demand00
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The Global Development Plan (GDP): Your Roadmap To Drug/Device DevelopmentAlbert YehaskelOn-demand00
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The Nuts and Bolts of a Quality Manual: Avoiding Pitfalls and Ensuring ComplianceAlbert YehaskelOn-demand00
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The Investigator Meeting – Regulatory Requirements and Obligations that Ensure SuccessAlbert YehaskelOn-demand00
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The Investigational New Drug (IND) Submission – Tips to Win the First TimeAlbert YehaskelOn-Demand00
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Successful FDA Interactions – Practical Approaches to Ensure Positive OutcomesAlbert YehaskelOn-demand00
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Project Management & Execution for Pharma/Biotech Manufacturing Facilities – A Step-by-Step GuideDwipen GhoshOn-Demand00
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FDA’s Mandate Requiring Conformance to SEND and SDTM for Pharma Submissions: What is the Vision?Laura KaufmanOn-demand00
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20
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Shed the Weight! Developing Standard Operating Procedures According to Lean PrinciplesDenise LaceyOn-demand00
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Using The ACE Program For FDA Imports – Ensuring Compliance & Speedy Product DeliveryCasper UldriksOn-demand00
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10