COURSE ID 2244

GMP in a Nutshell: Introduction to Current Good Manufacturing Practices

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

James Vesper, PhD, MPH

Price
$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

The quality of pharmaceutical products is subject to rigorous scrutiny and meticulous control because anything less than the best possible quality could result in regulatory issues. More importantly, compromised quality could jeopardize patient safety, leading to potentially serious health risks. Current Good Manufacturing Practices (cGMPs) are regulations (21CFR210-211) used to ensure consistency in the manufacture of quality healthcare products. These regulations involve various departments in the manufacturing process.

As consumers of pharmaceutical products, whether they are prescriptions (“RX”) or over-the counter (“OTCs”), we expect them to be safe, pure, and effective. It is up to those manufacturing and testing these products to ensure that current good manufacturing practices (cGMPs) are followed from the acquisition of raw materials to the distribution of the final dosage forms. Health authorities like the US Food and Drug Administration (FDA) periodically conduct inspections of facilities to ensure that the cGMP regulations are implemented and followed.

In this 90-Minute accredited training, participants will be provided an overview to GMPs for pharmaceuticals and the current U.S. FDA regulations. Seven Essentials of GMPs and examples of compliance versus non-compliance will be covered as well as the consequences for non-compliance.

Upon completion of this course, you will be able to:

  • Define key words and concepts related to current good manufacturing practice (cGMPs).
  • Identify key events that contributed to the cGMPs.
  • Describe how the regulations, guidelines, best of industry practice, and other factors contribute to “Current GMP expectations.”.
  • Define the characteristics of a cGMP-compliant product.
  • Discuss how quality system elements apply to your role and responsibilities.
  • Identify the range of actions that can happen in the case of non-compliance with cGMPs.
  • Identify the Seven Essentials of GMPs and discuss current GMP expectations that are relevant to your role and responsibilities.

COURSE OUTLINE

Where did the GMPs come from? Why do they exist?

  • Focusing on the patient
  • A quick look at 21 CFR 210 and 211
  • SISPQ-A: Characteristics of a GMP-compliant product

What makes for “current” good practice?

  • “Feasible / valuable,” guidelines

Seven Essentials of GMP

  • Protect the product from contamination
  • Prevent mix-ups
  • Know what to do – and why – before doing it
  • Document what really occurred (including data integrity)
  • Strive for consistency and control
  • Have management support and independent group that makes the final decisions
  • Monitor, solve problems, and continually improve

Examples of non-compliance

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This course is designed for quality professionals, production and manufacturing technicians, packaging, distribution, and labeling staff, validation staff and any other sponsor organization representative that contract to GMP vendors and needs to understand the regulations.

This course is also for any others looking to enter the GMP sector or within the following industries:

  • Pharmaceutical Science
  • Biologics
  • Research & Development
  • Veterinary Drug Products

Course Instructor

James Vesper

James Vesper, PhD, MPH

Director of Learning Solutions at ValSource

James Vesper, PhD, MPH’s Courses

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