2021 FDA/PDA Joint Regulatory Conference September 27 - 29, 2021

Virtual | Virtual

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• Date: September 27 - 29, 2021

Registration and Agenda

Location: Virtual

Background:

Since 1991, the FDA/PDA Joint Regulatory Conference has offered the opportunity for participants to join FDA representatives and industry experts in education and dialogue concerning significant regulatory issues. Each year, FDA speakers provide updates on current efforts affecting the development of global regulatory strategies, while industry professionals from pharmaceutical companies present practical approaches to assuring quality through robust  quality systems and drug manufacturing.

Through a series of plenary and breakout sessions, this conference will provide opportunities for attendees to learn about critical issues to manufacturing and quality including:

• Implementing practical approaches and effective practices that assure sustainable CGMP (Current Good Manufacturing Practice) compliance in the pharmaceutical industry.
• Emerging inspection and compliance trends.
• Use of quality risk management (QRM) and knowledge management throughout the pharmaceutical manufacturing lifecycle to support an ongoing state of control of facilities and processes.
• The evolution and optimization of the quality assurance role in the industry.
• Integrating executive oversight into the global business platform to assure ongoing commitment to reliable manufacturing, and avert quality and supply problems.
• Presentation of case studies demonstrating effective use of CAPA, change management, process performance and product quality monitoring, and management review to drive consistency and continual improvement.
• Establishing and implementing harmonization of industrial and regulatory approaches to benefit the consumer.

Goals and Objectives

The conference, celebrating its 30th anniversary, will emphasize the role of robust pharmaceutical quality systems in ensuring state of control.  Key themes will include supply chain reliability, elements of an effective quality system, quality assurance, ongoing assessment of process capability, the facility and equipment lifecycle, continual improvement, quality risk management techniques, and leveraging beneficial manufacturing innovations.  Case studies throughout the meeting will provide real experiences faced by the industry as it strives to adopt these concepts. The conference will focus on approaches that facilitate sustainable compliance with CGMPs and addressing emerging risks to manufacturing and supply chain reliability.  It will provide forums for open discussion between FDA representatives and industry experts and offer opportunities for the application of approaches that enhance assurance of raw material quality, quality assurance management of contract manufacturing relationships, barrier technology, upstream detectability, data analytics, and root cause analysis. Additionally, the conference will serve as a forum for sharing best practices across the product lifecycle including medical products technical transfer, defect prevention, shortage prevention, and continual improvement activities through use of well-managed operations and appropriate quality standards. The FDA and Parenteral Drug Association (PDA) have agreed to leverage their combined strengths for the joint development of the substantive actions of this conference to meet these objectives.

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, including 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, quality assurance, lifecycle quality risk management, practical case studies, and global regulatory strategies.

Contacts:

If FDA: Lorraine Wood – lorraine.wood@fda.hhs.gov

If PDA: Molly E. O'Neill – oneill@pda.org