Introduction To Pharmaceutical GMPs

Overview

Introduction to Pharmaceutical GMPs focuses the participant on understanding the key components of 21 CFR 210 and 211. This introductory course provides baseline knowledge of these regulations through engaging interactions and exercises.

Course Outline

• What are GMPs?
• The History of GMPs
• Introduction to 21 CFR 210
• Subparts A,B,C and the application at your organization
• Subparts D,E, F and the application at your organization
• Subparts G,H,I and the application at your organization
• Subparts J and K and the application at your organization
• How GMPs are enforced
• FDA Enforcement Actions

**Class Length 4 - 6 Hours depending on customization
**Prerequisites: None

The Problem

• Are you a GMP regulated facility that needs interactive and fun training?
• Do you need a fresh and energetic way to train new and current employees on GMPs?
• Do you need a GMP program that really teaches your employees the fundamentals of this important regulation?
• When asked what GMP is, do your employees say, “Huh?”

Our Solution
To Learn...

• The basic components of GMPs and how the regulation is organized and documented
• The connection between the regulations and activities and SOPs at your firm.

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