2018 PDA/FDA Joint Regulatory Conference
Sept. 24, 2018 – Sept. 26, 2018 • Renaissance Washington, DC Downtown HotelRegistration
The PDA/FDA Joint Regulatory Conference, now in its 27th year, provides a forum for discussions centered on the requirements that assure the availability and delivery of high-quality medical products, and offers an opportunity to hear about the latest issues in the regulatory, quality, supply, and compliance areas for medical products in an ever-evolving landscape. Attendees will hear straight from regulators and industry leaders about how to meet the challenges of developing, manufacturing, and assuring availability and safe supply of necessary medicines to serve the patient.
In keeping with the focus on putting patients first, this important Conference will explore topics that ensure innovation, quality, compliance, and a continued supply of important drugs, biologics, and combination products.
The Conference program will include discussions on combination products, aging facilities, quality risk management, post-approval changes and life-cycle management, process validation, and challenges of regulatory application submissions. Hot topics, such as aseptic processing, managing enforcement actions (e.g., consent decrees), inspection updates, quality systems, and quality trending, among others, will also be addressed.
Plenary and breakout sessions will include case studies and practical solutions to current supply challenges, such as shortage prevention and disaster recovery, management of contract manufacturers, supplier oversight, supply chain challenges for innovative products (e.g., cell and gene therapy), and supply chain safety.
The agenda is also packed with extensive technical content on other topics, including quality culture, effective training, data integrity, manufacturing innovation, current aseptic processing issues, water systems, and much more!
FDA Center and Compliance Update sessions are back by popular demand! And, be sure to attend the Q&A breakfast session with FDA Center and ORA experts!
Join 1,000 of your peers and engage with regulatory experts from the U.S. FDA and other global regulatory authorities at this signature event.