Creating an Effective and Compliant CAPA System - Abbreviated Version

The Association for GXP Excellence (AGXPE) is pleased to announce our upcoming 90 minute interactive webinar hosted by Imran Husain (Celeritas), and CAPA experts Nancy Singer and Kim Meija.

The session will discuss CAPA practices that the FDA finds compliant, and highlights issues that typically exist with existing practices at most organizations. Participants will hear about observations that FDA investigators are typically citing life sciences firms for, in failing to establish an effective CAPA system.  Ineffective CAPA systems, that don’t comply with regulatory requirements, lead to significant time and money being wasted.

Key Topics:

• How to apply key definitions to the organization’s CAPA activities
• Essential provisions of a compliant CAPA procedure and examples of missing provisions
• How to establish criteria to escalate non-conformity to a CAPA and apply criteria to nonconformances
• How to apply timeframes for closing CAPA
• How to design effectiveness checks

ABOUT THE PRESENTERS:

Kim Mejia, Executive Director 

Kim is a Quality Management/Regulatory leader with over 25 years of experience in the medical device and BioPharma industry. The industry expertise focus areas are medical devices and pharmaceutical auditing, including to QSR, cGMP, and ISO 13485, ISO 14971 standards and CAPA excellence and effectiveness. Kim holds a Bachelor of Science degree in Biochemistry from Emmanuel College in Boston, MA, magna cum laude, and an MBA from Bentley University in Waltham, MA (with distinction). While working at the Massachusetts Institute of Technology, she co authored an article published in Science on “Genetic Control of Programmed Cell Death in Drosophila.” She served as a panelist at the Regulatory Affairs Professional Society (RAPS), AdvaMed , ASQ and AGXPE meetings on topics ranging from CAPA excellence to effective communication and maintaining composure during FDA inspections. Kim serves as the Vice President of the New England Chapter of the Association for GxP Excellence.

Nancy Singer, Former Special Counsel 

Nancy founded Compliance Alliance LLC in 2004 to specialize in the professional development for industry and government officials in the health care industry. She is an assistant professor at George Washington University School of Medicine and Health Sciences and has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. She presently teaches courses in good documentation practices for FDA’ s ORA University, FDA District Offices, and FDA Staff Colleges. Previously she served as Special Counsel for the Advanced Medical Technology Association ( AdvaMed ). She was a co author of AdvaMed’s Points to Consider When Preparing for an FDA Inspection Under the QSIT Corrective and Preventive Action Subsystem. For her efforts to improve the FDA inspection process, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently, she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired Commander in the US Navy Reserve.