New ICH & EMA Quality Guidelines

https://fleming.events/new-ich-and-ema-quality-guidelines/

In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.

Key topics:

• ICH Q12 Lifecycle Management
• ICH Q13 Continuous Manufacturing
• EMA Guideline on quality documentation for medicinal products when used with a medical device
• ICH Q14 Analytical Procedure Development
• ICH Q2(R2) Analytical Validation
• Current EMA Quality Discussions and Initiatives

Training audience:

• Regulatory affairs
• QA/QC
• Analytical Development
• R&D Scientists
• Manufacturing Scientists
• CMC
• GMP
• Regulators