CGMP Overview for Pharmaceuticals

This overview of 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

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

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