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10: Regulatory Compliance/Requirements and Guidance

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Learning Objectives:
  • Part I: Understanding Regulatory Requirements
    • Regulatory compliance: Regulations and responsibilities (GLP & cGMP)
    • ICH, FDA, EMA
    • Pharmacopeia: USP, JP, BP
    • Change Control, Submission, Annual Reports
  • Part II: Maintain Compliance Status
    • Laws and Regulations
    • Types of FDA Inspections
    • Warning letters
    • Preparing for an Inspection