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Event Title
2024 PDA/ FDA Joint Regulatory Conference
September 9 - 11, 2024

Date:
September 9 - 11, 2024
Day1:
Mon, Sep 09 7:15 a.m. - 05:00 p.m. ET
Day2:
Tue, Sep 10 7:15 a.m. - 05:00 p.m. ET
Day3:
Wed, Sep 11 7:15 a.m. - 05:00 p.m. ET

About

FDA and Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference to emphasize the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle.

The conference will:

  • focus on the vital role of robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization and quality risk management, which are fundamental to current good manufacturing practice (CGMP) compliance
  • include case studies to provide practical insights and illustrate how sustainable compliance establishes the foundation for quality and supply consistency
  • highlight international collaboration efforts that improve quality and benefit consumers

This conference is designed to share systemic and preventive approaches that are foundational to CGMP compliance, and ensure effective ongoing management of manufacturing and supply chain risks.

The conference also will provide an open discussion forum between FDA representatives and industry experts, and offer opportunities for practical insights into a wide variety of current topics relating to manufacturing and quality. Examples include:

  • building CGMP-compliant quality systems
  • conducting robust investigations
  • avoiding cybersecurity and data integrity risks
  • assuring effective external supplier selection and auditing
  • use of current manufacturing technologies to assure CGMP compliance
  • update on latest CGMP guidances
  • upgrading aging facilities
  • effective implementation of quality assurance authority
  • de-risking your quality control laboratory

Visit 2024 PDA/FDA Joint Regulatory Conference for more information.

Who Should Attend:

  • pharmaceutical companies
  • regulatory agencies
  • academia
  • quality assurance experts
  • manufacturing experts and leaders in the U.S. and abroad

Contact:

Lorraine Wood
FDA/Center for Drug Evaluation and Research/Office of Compliance
lorraine.wood@fda.hhs.gov

Molly O’Neill
PDA’s Vice President, Programs & Meetings
oneill@pda.org

 

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