An Overview of the FDA Pharmaceutical GMP Regulations


An Overview of the FDA Pharmaceutical GMP Regulations


Delivery: Immediate (Electronic Download)

Format: HTML/Flash in a ZIP archive


Course Outline

  • History of US pharmaceutical regulation
  • What regulations are there?
  • Current "GXP" regulations
  • 21 CFR 210
  • 21 CFR 211
    • Subpart A - General Provisions
    • Subpart B - Organization and Personnel
    • Subpart C - Buildings and Facilities
    • Subpart D - Equipment
    • Subpart E - Control of Components, Containers and Closures
    • Subpart F - Production and Process Controls
    • Subpart G - Packaging and Labeling Control
    • Subpart H - Holding and Distribution
    • Subpart I - Laboratory Controls
    • Subpart J - Records and Reports
    • Subpart K - Returned and Salvaged Drug Products
  • Where does your job fit in?
  • Summary
  • Knowledge assessment

Course Length:

30 minutes plus the time to take the Knowledge Assessment

Who Should Take This Course:

New employees as an introduction to the GMP Regulations, and veteran employees to meet the on-going GMP training requirement

Flexible Delivery:

This course can be delivered to a group in a classroom setting, or online to individuals.

Special Features:

  • Interactive section "Where does your job fit in?" branches to common pharmaceutical departments and discusses which GMP requirements must be met for those functions - especially valuable for new employees
  • Narration frees trainer from time-consuming preparation (narration can be optionally muted if trainer wants to deliver personally)
  • Periodic, interactive review questions
  • Participatory learning where trainees click on topics for more information
  • Knowledge assessment for documented evidence of program understanding
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