Level: Introductory

Delivery: Virtual, instructor-led, interactive

Overview

This is an introductory course covering the key concepts related to current Good Manufacturing Practices (cGMP) in biopharmaceutical manufacturing. 

Audience

his course is designed for operators, technical staff, engineers, and managers who want to develop their knowledge of how Good Manufacturing Practices (GMP) are applied in the biopharmaceutical manufacturing industry.

Key Topics

• Current Good Manufacturing Practices (cGMP)– scope, application and impact on work in the pharmaceutical industry
• Good Documentation Practices (GDP) in pharma: importance and challenges
• Introduction to main unit operations in biopharmaceutical manufacturing
• Upstream, downstream, and fill-finish processing theory

Learning Objectives

Upon completion of this module, trainees will be able to:

• Explain the key components of cGMP
• Understand the main acronyms in GMP, such as SOP, CAPA, QA, QC and more
• Describe the unit operations in upstream, downstream, and fill-finish in a biopharmaceutical production process
• Describe the need for aseptic processing and contamination control in a cleanroom environment

Duration: Half-day

Assessment
A competency-based assessment will be performed at the end of the course to certify proficiency regarding course topics and learning objectives.