Regulators & Industry Address Missing Links in Continuous Manufacturing
FDA’s Draft Guidance on Emerging Technologies is another step in the commitment that Regulatory Agencies have made in working with the pharmaceutical industry toward effective implementation of continuous operations. However, the implementation of this new manufacturing system presents many challenges.
ISPE’s Continuous Manufacturing Conference has been designed by Regulators and the pharmaceutical industry to address the challenges – in both small and large molecules.
Broad regulatory involvement in this new conference makes it the ideal setting for you to gain a clear understanding of the benefits and obstacles of transforming your operations, along with the regulatory and lifecycle considerations involved. Key topics include:
- Global Regulatory Considerations – FDA and EMA
- Making the Case for Continuous Manufacturing – Johnson & Johnson
- Drug Product: Portable, Continuous, and Modular – Pfizer (2016 Facility of the Year Awards Category Winner for Equipment Innovation)
- End-to-End Manufacturing – Novartis
- PAT and Control Strategy in API Manufacturing – Eli Lilly
- Process Validation in Continuous Manufacturing – Vertex
- Continuous Manufacturing for Bio Processes – Genzyme
- Sampling Considerations – Merck
- Challenges in Implementation of Continuous Manufacturing – Bristol-Myers Squibb
- Funding Opportunities from BARDA
Take the opportunity for technical discussion and your company’s input at the following workshops:
- Control Strategy
- Process Validation
- End-to-End Manufacturing
- cGMP Considerations
- Lifecycle Implementation
Ready to implement this highly-effective model for efficient drug manufacturing? Register for the Continuous Manufacturing Conference today.
Student and Group Discounts are Available