Online
Overview of China NMPA and Pharmaceutical GMP Regulations
To succeed in China's dynamic pharmaceutical landscape, you must first have a good understanding of the China National Medical Products Administration (NMPA), how China regulates drugs, and China's pharmaceutical Good Manufacturing Practices (GMP) regulations. Speaker: Andrew Chen, J.D. Chief Representative, Shanghai Office of Arnold &...
Artificial Intelligence in Drug Development
Date: Thursday | March 28, 2024 Time: 12 noon to 1pm PT Location: Zoom Registration: Free for OCRA-DG members; $20 for nonmembers Artificial intelligence (AI) and machine learning (ML) technologies have the potential to advance drug development in multiple areas, including candidate identification and refinement,...
Job Interview Virtual Workshop
Job Interview Techniques & Practical Role-playing with Industry Experts Join us at this special virtual event that aims to assist participants in navigating effective job interview strategies and techniques, offering invaluable advice from a panel of seasoned regulatory/quality and human resources experts. Gain insider tips...
Quality System Audit Best Practice, Tips & Tricks for Finding Mitigation
Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Webinar Join us for an insightful webinar where we'll delve into comprehensive strategies and tactics to help ensure your organization is prepared for your next...
FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance
FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device quality assurance, regulatory affairs, and R&D leaders and practitioners. Platform: Zoom In April 2023 FDA...
China Medical Device Registration Clinical Pathways Latest Updates
OnlineChina Medical Device Registration Clinical Pathways Latest Updates Date: Wednesday, June 6, 2024 Time: 8am – 9am PT Audience: Regulatory and clinical professionals in medical device industry Platform: Zoom Struggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence?...
What’s New in FDA 510(k) & eSTAR Best Practice
OnlineWhat's New in FDA 510(k) & eSTAR Best Practice Date: Wednesday, June 26, 2024 Time: 12 noon – 1pm PT Audience: Medical device regulatory affairs professionals who are involved in the 510(k) submission process. Platform: Zoom The panel will provide an overview of the recent...
Summer Social
Bosscat Kitchen & Libations 8169 Von Karman Ave,, Irvine, CA, United StatesSocial Summer Date: Friday, July 12, 2024 Time: 4 – 8pm PT Location: Bosscat Kitchen & Libations 18169 Von Karman Ave, Irvine, CA 92612 Free for Member $10 for Nonmember Register Now!
Navigating EU MDR Compliance for CE Marking
OnlineNavigating EU MDR Compliance for CE Marking Date: Thursday, September 12 Time: 12pm-1:15pm PT Audience: This webinar is recommended for professionals with some familiarity with EU MDR or the previous Medical Device Directive (MDD). Platform: Zoom This webinar aims to provide an overall understanding of...