- September 18 - 20, 2023
- - ET
- - ET
- - ET
The PDA/ FDA Joint Regulatory Conference. The meeting will be held Sept. 18-20, 2023 at the Renaissance Washington, DC Downtown Hotel 7:15am - 5:00 pm EDT.
**Remote conference access is available, upon request. **
Goals and Objectives:
The FDA and Parenteral Drug Association (PDA) are leveraging their combined strengths in this annual joint Current Good Manufacturing Practices (CGMP) conference – now in its 32nd year.
The CGMP conference will emphasize the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. The vital role of robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized as fundamental to CGMP compliance. Case studies presented throughout the conference will provide practical insights and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts to improve quality and benefit consumers will also be highlighted.
The 2023 PDA/FDA Joint Regulatory Conference is designed to share approaches that facilitate sustainable compliance with CGMPs by address emerging risks to manufacturing and supply chain reliability. The conference will provide forums for open discussion between FDA representatives and industry experts, offer opportunities for practical insights into building an effective quality assurance program in accord with CGMP. The conference will also provide discussion on identifying the right subject matter experts for conducting investigations, ensuring quality in cell therapy, and the latest published quality guidances. The conference will also serve as a forum on the importance of supplier communications, upgrading aging facilities, innovations for CGMP training, and continual improvement activities through use of well-managed operations and appropriate quality standards.
Participation in this conference supports objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This conference is also consistent with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Public Law 104-121), as an example of outreach activities by Government agencies to small businesses.
Who Should Attend:
The primary audience includes interested pharmaceutical companies, regulatory agencies, and academia, quality assurance experts, manufacturing experts and leaders in the US and abroad who use the conference to stay informed on significant regulatory issues relating to current good manufacturing practice compliance through quality assurance, lifecycle quality risk management, practical case studies and global regulatory strategies.
If to FDA:
Center for Drug Evaluation and Research
Office of Compliance
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
If to PDA:
Vice President, Programs & Meetings
Parenteral Drug Association (PDA)
4350 East-West Highway, Suite 600
Bethesda, MD 20814