Good Manufacturing Practices (cGMP) - Intermediate

Technology Transfer to GMP Manufacturing

In this course, learners will explore the foundations of tech transfer to GMP environments. First, they begin with what tech transfer is, examples of successful tech transfer, and challenges that it may face. Next, they navigate the four stages of tech transfer, from Project Initiation through Review and Closeout.

CEU Credits: 0.1

Course Code: ELM-729

Duration: 20 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: v1.0

Effective Date: 10/10/2024

Curriculum for this course

Welcome

Course Introduction

Technology Transfer Overview

What is technology transfer?

Successful Technology Transfer

Reasons to Perform Technology Transfer

Technology Transfer Challenges

Technology Transfer Process

Tech Transfer Process Overview

Project Initiation: Organizational Structure

Communication Plan

Feasibility Studies

Project Planning: Information Exchange

Document Transfer

Transfer Protocol

Gap Assessment

Equipment Gap Assessment Example

Risk Assessments

Risk Assessment Example

Project Plan Execution

Success Criteria

Project Review and Closeout

Conclusion

Summary

Test Your Knowledge

Revision History

v1.0 - Course Released on 11/26/2024

Author

Timothy Frade

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