Register for the 2022 PDA/FDA Joint Regulatory Conference In this co-sponsored conference, the FDA, and the Parenteral Drug Association (PDA) will provide opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. The 2022 conference takes place Sept.12-14 in Washington, D.C. An extensive agenda has been developed to assist companies with current good manufacturing practice (CGMP) compliance, which leads to robust quality and supply. As always, sessions will include expert insights into assuring high manufacturing capability and quality, along with numerous practical case studies. The following are examples of some of the sessions at this conference: - Responding effectively to FDA 483s
- De-risking human error potential through good design
- Supply chain reliability
- Sustainable CGMP compliance
- Facility and equipment lifecycle oversight
- Quality Risk Management
- Leveraging beneficial manufacturing innovations
- Newly issued FDA guidances
In addition, highly popular annual sessions will return again this year that include panelists from multiple FDQA Centers, including CGMP Update, Center Director Update, and Lunch with the Regulators. Senior leaders and subject matter experts from both the agency and industry will present at the conference. FDA leaders include multiple Center Directors, the Office of Regulatory Affairs (ORA) Associate Commissioner for Regulatory Affairs (ACRA). These include: - Dr. Peter W. Marks, MD, Center Director (CBER)
- Dr. Steven M. Solomon, MD, Center Director (CVM)
- Dr. Jacqueline Corrigan-Curay, JD, Deputy Center Director (CDER)
- Dr. Judith A. McMeekin, ACRA (ORA)
- Alonza Cruse, Director, Office Pharmaceutical Quality Operations (ORA)
Follow this link for the extensive conference agenda and information on registration. |
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