Pharmaceuticals cGMP Fundamentals Course

The Pharmaceutical cGMP Fundamentals training course is recommended for those who want to work in entry-level pharmaceutical manufacturing roles.

English Version

Spanish Version

COURSE OVERVIEW

This course offers a comprehensive introduction to current Good Manufacturing Practices (cGMP) governed by industry regulations and guidelines (set by agencies like the FDA and EMA), which are the foundation of the pharmaceutical industry. The course delves into pharmaceutical manufacturing processes, covering cGMP principles, facility design, validation principles, and production activities, all geared towards ensuring product quality and safety.

Duration:

4 Weeks

Format:

In-Person

Start Date:

Rolling Start Dates

Course Level:

Entry Level

Certification Earned:

Certificate of Completion

WHY CHOOSE THIS COURSE?

Choosing a course like this offers numerous benefits, especially for individuals looking to advance or begin a career in the pharmaceutical manufacturing industry. One of the key advantages of this course is its emphasis on hands-on learning and production environment simulations. Unlike traditional classroom-based courses, this program offers interactive and practical experiences inside a GMP-compliant manufacturing facility and provides visibility to various sustainable pharmaceutical career paths.

COURSE HIGHLIGHTS

Some additional benefits of this hands-on training approach include:

Immediate feedback and correction where trainers can observe students’ actions, identify errors or inefficiencies, and provide timely guidance for improvement.
Team collaboration to encourage effective communication and coordination among students.
Risk-free learning environment for students to make mistakes and learn from them without jeopardizing actual products, equipment or processes.
Enhanced retention and application where students who actively participate in hands-on training are more likely to remember and apply the knowledge and skills they have acquired during training.

COURSE OBJECTIVES

Gain an understanding of the Pharmaceutical Industry and Career Paths

Obtain an industry overview, learn about the product development lifecycle, become aware of emerging trends and the rapidly growing local DFW ecosystem.
Gain exposure to various sustainable career ladders/paths and opportunities within the industry.

Understand Industry Culture

Learn about the professional culture and the code of ethics and compliance within the industry.
Appreciate the importance of teamwork, communication, and collaboration in a regulated environment.

Achieve Proficiency in cGMP Principles

Apply Good Documentation Practices (GDP) and understand the need and importance of change control and deviations management.
Understand the requirements of a robust quality management system (QMS).

Comprehend Facility Design and Maintenance Requirements

Acquire basic understanding of the facility design requirements and considerations for a cGMP facility.
Gain exposure to facility maintenance activities including, but not limited to: access control, sanitization, pest control and metrology.

Understand Validation Principles

Learn the importance of equipment and process validation that are an essential prerequisite for production activities.
Develop rudimentary understanding of validation lifecycle and fundamental skills by performing simple qualification activities.

Learn Key Operations Processes

Acquire an understanding of the essential manufacturing operations processes including but not limited to: warehousing, batch record execution, product inspections, packaging and distribution.
Understand the importance of aseptic technique and the different levels of gowning based on the various environmental zones within a cGMP facility.

WHO SHOULD ENROLL

Anyone looking to gain exposure to current Good Manufacturing Practices via interactive and hands-on training, with the ultimate goal of working in the pharmaceutical manufacturing industry.