The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 29th year. This flagship conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and related compliance issues in an ever-evolving landscape. This year’s theme is “The Future Is Now: Effective Quality Management and Robust Manufacturing,” and will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. The conference proceedings will delve into the details through the discussion of latest innovative technologies, case studies, regulatory expectations, and forward-looking perspectives in sessions, such as:
- Commercialization challenges in cell and gene therapy
- Data analytics in manufacturing
- De-risking your Supply Chain
- The Quality Assurance role in 2020 and beyond
- ICH quality initiatives
- OOS investigations
- Process validation lifecycle
- Combination products, diagnostics, and software as a medical device
- U.S. FDA Emerging Technology Program
- Using risk management to reduce the risk of drug shortage
- Utilizing modeling in manufacturing
This year’s conference focuses on advancing quality management and the robust manufacturing of innovative drugs, biologics, and combination products. Combined efforts of industry and regulators are necessary to assure uninterrupted supplies of safe and high-quality products while advancing the use of new capabilities.
In addition to the above topics, attendees will also learn about hot topics such as supplier quality control, new large volume parenteral technical approaches, joint inspection program for sterile drugs, human performance tools to help strengthen deviation management, preventing nitrosamine impurities, and how regulators assess firms in times of crises. FDA senior officials will discuss Center-specific initiatives as well as provide compliance updates.