- September 12 - 14, 2022
- - ET
- - ET
- - ET
The PDA/ FDA Joint Regulatory Conference. The meeting will be held Sept. 12-14 at the Renaissance Washington, DC Downtown Hotel 7:15am - 5:00PM EDT.
***An option for remote access to the conference sessions will also be available.***
Goals and Objectives:
The FDA and Parenteral Drug Association (PDA) have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of this annual conference.
The conference will emphasize the role of robust pharmaceutical quality systems in ensuring state of control. Key themes will include leveraging the digital and automation revolution, contamination control strategy, latest FDA CGMP trends, how to respond effectively to FDA 483s, assuring supply chain reliability, the facility and equipment lifecycle, ICH update, and leveraging beneficial manufacturing innovations. Case studies will be presented throughout the meeting and will provide real experiences faced by the industry as it strives to adopt these concepts. The conference is designed to share approaches that facilitate sustainable compliance with CGMPs by address 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, root cause analysis, and use of current technologies (e.g., laboratory modernization, closed system processing, isolator technology, restricted access barriers, enhancing upstream detectability, better data analytics for monitoring quality and process capability) to ensure adherence to current GMP expectations. Additionally, the conference will serve as a forum for sharing practices across the product lifecycle that facilitate effective drug product technology transfer, prevention of defects, shortage prevention, 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, 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 through quality assurance, lifecycle quality risk management, practical case studies and global regulatory strategies.
If to FDA:
Office of Compliance
Building 51, Office 5283
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