Good Manufacturing Practices (GMP) in Biopharmaceutical Manufacturing

Level

Introductory

Format

Instructor-led, virtual

Duration

Half-day

Cost

$543

Overview

Good Manufacturing Practices (GMP) are essential when producing complex biopharmaceutical products, which require advanced contamination control strategies to ensure product quality and patient safety. These requirements affect everyone involved in the manufacturing process, whether directly or indirectly. This course offers a high-level overview of the full biopharmaceutical manufacturing workflow—from vial to vial—while connecting each process step to the regulatory expectations and operational context of GMP.

Why It’s Essential

Understanding the context of GMP as it applies to biopharmaceutical manufacturing is essential for anyone working in or supporting a production environment. This course helps participants appreciate how the responsibilities of different functions intersect to uphold quality and patient safety. By expanding this perspective, the program strengthens cross-functional awareness, improves collaboration, and enhances overall team effectiveness.

Learning Objectives

• Explain the core principles of GMP

• Become familiar with contamination prevention and control strategies

• Describe the unit operations in upstream, downstream, and fill-finish in a biopharmaceutical production process

• Describe the need for aseptic processing in a cleanroom environment

Who Should Attend

This course is designed for individuals across the biopharmaceutical industry who seek a fundamental understanding on how Good Manufacturing Practices are applied in biopharmaceutical manufacturing, including:

• Operators and technicians supporting day-to-day bioprocess operations

• Engineers involved in upstream, downstream, or overall process development and manufacturing

• QA/QC associates ensuring quality, compliance, and product integrity across process stages

• Managers overseeing production, technical teams, or facility operations

• Clinical trial personnel working with investigational biologics or supporting manufacturing-readiness

• Supply chain professionals responsible for materials, logistics, or production planning

• Anyone working directly or indirectly in the manufacturing and/or development of biopharmaceutical products

Participants who successfully complete a theoretical assessment will receive a certificate of completion.