CGMP Overview for Pharmaceuticals

CGMP Overview for Pharmaceuticals

CGMP for Pharma outlines the fundamentals of current Good Manufacturing Practices (CGMP) used by pharmaceutical and biomanufacturing companies. CGMP exists to protect the health and safety of patients and consumers which supports the mission of the Food and Drug Administration (FDA). This course equips professionals whose responsibilities depend on operating in CGMP and regulated facilities.

Audience

  • Manufacturing Technicians
  • Team Leaders and Supervisors
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Maintenance / Engineers

Topics Include

  • Mission of the FDA
  • Quality Assurance Role
  • Personnel and Organization
  • Buildings and Facilities
  • Equipment
  • Control of Components, Drug Product Containers and Closures
  • Production and Process Controls
  • Packaging and Labeling
  • Holding and Distribution
  • Laboratory Controls
  • Records and Reports
  • Return and Salvaged Drug Products
  • Complaints and Recalls
  • Good Documentation Practices
  • Computer Systems (Part 11)
  • Regulatory Enforcement

Learning Objectives

  • Define the elements of current Good Manufacturing Practices (CGMP) for biomanufacturing and pharmaceutical production.
  • Explain how CGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211)
  • Understand the importance of current Good Documentation Practices (CGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (Electronic Record Keeping)
  • Recognize the consequences of failing to comply with CGMP
CGMP Overview for Pharmaceuticals

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Portability

This course may be taught at any location.

Delivery Format

  • Online

Level: Beginner

Lecture HoursLab or Activity HoursTotal

Instructor Pool

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