Good Manufacturing Practices (GMP): Sterile Manufacturing and Key Challenges

Tool: Microsoft Word

My Role: Instructional designer, researcher, eLearning script & storyboard writer

Note: This module was one of 29 modules for the good manufacturing practice (GMP) curriculum. I wrote 90% of this curriculum for on-demand or off-the-shelf learning solution products for Red Nucleus Training Institute (RNTI) 

Learners: Life science companies interested in providing on-demand training to their teams on the importance of good sterile manufacturing practices

My Objectives:  

• Work with a subject matter expert to provide a self-paced eLearning module to discuss the importance of sterility in therapeutic products and provide an overview of good practices and requirements for facilities, management, and personnel 

• Include audio narration with a full-text transcript, varied page elements, interactive learning exercises, a summary, self-check questions, and a glossary

• Fully cite and source best practices and global health authority regulations and guidance

Learner Objectives:  

• State what sterile manufacturing is and why it's important

• List the elements that make up successful sterile manufacturing operations

• Identify the key requirements for successful sterile processing facilities and operations

• State personnel expectations to ensure an effective sterile production operation