Method
Live-Online
Term
SPRING
Units
3.0 QUARTER UNITS
Cost
$875

Skills you will gain

  • GMP & GLP Regulations: Understand the impact of FDA Good Manufacturing and Good Laboratory Practices on pharmaceutical operations.
  • Daily GMP Applications: Learn how GMP regulations are applied in everyday operations and their importance in maintaining quality.
  • Regulatory Controls in Manufacturing: Gain insight into regulatory controls and their role in drug and biopharmaceutical manufacturing.
  • Quality Assurance & Control: Develop a comprehensive understanding of quality systems in pharmaceutical production.
  • Industry Standards & Practices: Grasp why certain practices, attitudes, and environments are essential within a mature pharmaceutical company.

Course Description


Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions, and case studies, you’ll gain an understanding of the FDA GMP and Good Laboratory Practice (GLP) regulations. While primarily aimed at the manufacturing, quality control, and quality assurance worker, the course is also useful for regulatory affairs and clinical research professionals, as well as anyone who wants to understand which regulatory controls apply to the manufacture of drugs and biopharmaceuticals for human use.

Topics

  • History, Regulation, Good Laboratory Practice
  • General Provisions
  • Control of Components and Drug Product Containers and Closures
  • Biologics and Good Tissue Practice

Additional Information

The course will consist of four 6 hour sessions with a 45 minute lunch break and ~15 minute breaks every 1.5 hours.

The Instructor will provide the required text material in electronic format. By the end of the course, the student should have read the entity of the GMP regulations for drugs, biologics, and cell therapies. While the instructor may suggest the reading of guidance documents and other material, the GMPs will be the only required reading material.

Professional Credit

CA BRN/LVN Credit--Provider #CEP13114, 30 hours.

Syllabus Library
You may enroll in this offering at any time.
Romi Behbehanian
Romi Behbehanian
Apr. 18 - Jun. 6, Saturday, 12:00pm - 5:00pm
  • Live-Online Attend via Zoom at scheduled times.
REGL.X400.(15)
Schedule
Date Start Time End Time Meeting Type Location
Sat, 04-18-2026 12:00pm 5:00pm Live-Online REMOTE
Sat, 04-25-2026 12:00pm 5:00pm Live-Online REMOTE
Sat, 05-02-2026 12:00pm 5:00pm Live-Online REMOTE
Sat, 05-09-2026 12:00pm 5:00pm Live-Online REMOTE
Sat, 05-16-2026 12:00pm 5:00pm Live-Online REMOTE
Sat, 05-30-2026 12:00pm 5:00pm Live-Online REMOTE
Sat, 06-06-2026 12:00pm 5:00pm Live-Online REMOTE
 

This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.

No meeting on May 23, 2026 and one additional “no meeting” TBA. To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

Required Text:
https://www.ecfr.gov

This course applies to these programs:

Demo