Former Associate Director, TOPV
2:35 PM Application of Life-Cycle Concepts from the ICH and FDA to Supply Cold Chain with a Focus on Continued Verification
With the FDA’s adoption of policies favoring continuous improvement and use of new technologies, biopharma cold chain sector will also experience fast paces changes for the better. Ajay is working on implementing new innovations within validation requirements and their 45 Million USD budget to improve profitability.
- Discuss ICHQ12 guidance in order to utilize flexibility across the supply chain
- Improve the quality of design method by adding trials and studies
- Assess distribution, R&D investments, and various studies on distribution and temperature