2019 PDA/FDA Joint Regulatory Conference

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 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 evolution 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 latest innovative technologies, case studies and 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