Years before the COVID19 pandemic, continuous manufacturing has been a topic of discussion within the pharmaceutical industry. Right now, continuous manufacturing is being used to manufacture a handful of products. In and beyond the pandemic, the nation’s legislators and regulators are seeking to rapidly expand the utility of continuous manufacturing to secure the pharmaceutical supply chain and to repatriation pharmaceutical manufacturing. In today’s dynamic geopolitical complexities and business environment, how should the pharmaceutical development and manufacturing sector factor in continuous manufacturing in their decision-making process? This webinar will be conducted in a live interview format to address this and other questions about the regulatory uncertainty on the adoption of continuous manufacturing.
During this session, you will learn from industry expert, Ajaz S. Hussain, PhD, as he discusses a thorough understanding of the current regulatory environment. As a result you will learn:
- Perceptions on why the pharma industry has been slow and skeptical in embracing the continuous manufacturing strategy
- What's the right manufacturing strategy: the batch versus continuous manufacturing
- Regulatory pathway for conversion from batch to CM for a commercial
- FDA's guidance on control strategy