Workshop C: Balancing Regulatory, Operational and Market Demand of Emerging Products
Time: 2:30 pm
day: Pre-Conference Workshop Day
Details:
This workshop panel will deep dive into the complexities of existing facilities achieving GMP compliance for radiopharmaceutical production. Participants will delve into the regulatory requirements, operational challenges, and strategic considerations necessary for successful facility transformation.
This workshop will cover:
- Understanding GMP Regulatory Requirements: Discuss the specific regulatory standards that facilities must meet to achieve GMP compliance, focusing on the unique challenges posed by radiopharmaceutical production. Explore how these regulations impact the design and operational workflows of facilities.
- Addressing Operational Challenges in Retrofitting: Examine the operational difficulties associated with existing facilities, such as integrating new technologies, managing contamination risks, and ensuring continuous production during renovations. Identify best practices for minimizing disruptions and maintaining quality control throughout the process.
- Strategic Considerations and Case Studies: Review case studies of successful facility projects by highlighting the strategies used to overcome regulatory and operational challenges and discussing the financial implications, including cost-benefit analysis, and the role of strategic planning in ensuring long-term compliance and operational efficiency.
