Elements of Current Good Manufacturing Practices for Pharmaceuticals

Elements of Current Good Manufacturing Practices for Pharmaceuticals

Expand your knowledge. Learn to apply current good manufacturing practices (CGMP) in biopharmaceutical production. CGMPs exist to protect the health and safety of patients or consumers.

In this course, we cover current regulations found in the selections of 210/211 of Title 21 of the Code of Federal Regulations (CFR) plus relevant ICH and FDA guidance documents.

Audience

This course equips professionals whose responsibilities depend on operating in CGMP and regulated facilities, including:

  • Manufacturing Technicians
  • Team Leaders and Supervisors
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Maintenance / Engineers – Aseptic Emphasis
  • Future Pharmaceutical Industry Employees

Topics Include

  • Buildings and Facilities
  • Equipment
  • Equipment Maintenance, Cleaning, and Calibration
  • CGMP Validation
  • Cleaning Validation
  • Production and In-process Controls
  • Materials Management
  • Packaging and Labeling
  • Laboratory Controls
  • Personnel
  • Complaints and Recalls
  • Change Control
  • Computer Systems

Learning Objectives

  • Explain the pharmaceutical industry’s good manufacturing practices.
  • Discuss the importance of maintaining a contaminant-free environment.
  • Define quality and discuss how quality products are important for safety and efficacy.
  • Describe the essential items identified by the Code of Federal Regulations and cGMP.
  • Explain validation principles and their importance to the industry from a quality perspective.
  • Discuss the consequences of good and poor quality.

Portability

This course may be taught at any location.

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Elements of Current Good Manufacturing Practices for Pharmaceuticals

Level: Beginner

Lecture HoursLab HoursTotal
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