Planning to meet GMP requirements globally

Stream: Regulatory Compliance

Defines GMP under international guidelines, identifies the standardisation and harmonisation efforts shaping the field, and sets out the criteria behind a defensible global manufacturing strategy.

Learning Objectives: 

• Define Good Manufacturing Practices and identify the key elements common to all major jurisdictions
• Identify the specific GMP challenges that cell and gene therapies present
  
• Apply harmonisation and standardisation considerations when developing a global
  manufacturing strategy

Modules: 

1. Introduction
2. Defining Good Manufacturing Practices (GMP)
3. Global GMP Context
4. Common Elements of GMP
5. Developing a Global Strategy
6. Recap

EST. COMPLETION 45 MIN - E-Learning format