The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) once again are cosponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 31st year. The previous two PDA/FDA Joint Regulatory Conferences were offered as virtual events due to travel and other restrictions brought about by the COVID-19 pandemic.
This year’s Joint Regulatory Conference will emphasize the role of implementing effective quality systems to ensure an ongoing state of control throughout the pharmaceutical product lifecycle by vigilantly managing quality risks. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management will be emphasized.
Case studies will be presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable Current Good Manufacturing Practice (CGMP) compliance establishes the foundation for drug quality and a reliable supply chain. The conference will also address international collaborations that aim to improve drug quality and benefit the consumer.
The Conference features the ever-popular FDA Center Office Updates, provided by the Office Directors of CDER, CBER, CVM, and by the Associate Commissioner of Regulatory Affairs of ORA. The FDA Center Directors and ORA’s Associate Commissioner of Regulatory Affairs will discuss recent programs, initiatives, and trends with respect to regulatory inspections and enforcement. The conference will also drilldown even deeper into compliance matters. Many sessions with practical GMP solutions and case studies throughout the conference culminating in the Current GMP Compliance Trends and Topics session, which will be held near the end of the conference (a perennial standing-room-only session). Just before the closing plenary session, attendees can have Lunch with the Regulators, another popular way for attendees to hear from FDA experts.
For more information, go to: https://www.pda.org/global-event-calendar/event-detail/2022-pda-joint-regulatory-conference
Members of the press can request a press pass here: https://www.pda.org/about-pda/press-pass-request-form