2018 PDA/FDA Joint Regulatory Conference
Putting Patients First: Ensuring Innovation, Quality, Compliance, and Supply in an Evolving Environment
This year marks the 27th year of the joint PDA/FDA conference. The conference will include several plenary sessions, and an extensive selection of breakfast and breakout sessions. The breakout sessions are comprised of three multi-day tracks that focus on assuring reliable manufacturing, quality, and supply, and promoting innovation. Highlights include:
- Lifecycle Management and Innovation: Hot topics regarding drug application submissions, post-approval changes (ICH Q12), aging facilities, process validation, combination products, and quality risk management.
- Quality and Compliance: Aseptic processing and EU Annex I; latest FDA inspection findings; compliance/enforcement trends; quality trending; effective quality systems; and consent decree lessons learned.
- Supply Chain: Effective audit programs, shortage prevention and disaster recovery, contract manufacturing oversight, ingredient supplier relationships; and innovative product challenges (cell and gene therapies).
Renaissance Washington, D.C.
September 24 – 26, 2018
The agenda includes more than 50 industry and regulatory experts covering extensive technical content on the above topics as well as quality culture, data integrity, manufacturing innovation, effective training, isolators and restricted access barrier systems, large volume parenteral manufacturing, water systems, container-closure integrity, pharmacy outsourcers, and much more.
- Learn about current FDA priorities from all medical product centers and the Office of Regulatory Affairs. Also, hear updates from European regulators, who will discuss their latest initiatives and collaborative activities.
- Focus on practical lessons learned through real-life industry case studies.
- Discuss factors affecting the quality and dependability of the supply chain, and the benefits of manufacturing modernization.
Visit PDA’s event registration page for more information and to register.