The Parenteral Drug Association (PDA) and the U.S. FDA are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, now in its 28th 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 compliance issues in an ever-evolving landscape.
This year’s theme is Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision, and the Conference will explore the continuing development of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. Plenary and concurrent sessions will delve into the details through the assessment of the latest innovative technologies, regulatory expectations, and forward-looking perspectives, including:
- CGMP challenges associated with cell and gene therapies
- Combination products and connected care applications
- Compliance updates and case studies
- Data integrity remediation and an update on the associated PDA Technical Report
- Designing aseptic processes to reduce quality risk
- Effective internal and external audits
- Evolving approaches to quality management systems
- Improving deviation and failure investigations
- Strategies for continuous improvement of facilities and equipment
- Use of augmented reality and artificial intelligence in manufacturing
This year’s Conference will focus on how advances in manufacturing, quality, and compliance are advancing the continued supply of innovative drugs, biologics, and combination products. Collaborative efforts between industry and regulators are necessary to assure uninterrupted supplies of safe and high-quality products while advancing the use of new capabilities.
Attendees will also learn about hot topics, such as inspection updates, laboratory controls, rapid microbiological methods, optimizing regulatory submissions, conducting effective smoke studies, and quality trending. Multiple interest groups will meet to discuss in-depth regulatory and compliance issues.
The Center Updates – the traditional FDA presentations from each of the medical product Centers – will return this year. Here, senior officials from the FDA will discuss Center-specific initiatives and provide compliance updates. The new Lunch with the Regulators (formerly Breakfast with the Regulators) session will provide an opportunity for attendees to ask their most pressing regulatory and compliance issues.
The lineup of speakers also includes regulators from agencies around the world and industry leaders who will explore the global regulatory issues facing industry.