The first meeting of the OCRA Leadership Circle will be Friday, Sept 15th, from 12:00-1:00pm PT, via Zoom. For more information, please contact Huong Huynh at membership@ocra-online.org For Members Only Do you have mentors, sponsors, and allies? Learn about these important supporters to your career journey....
Speaker: Steven Thompson Topic: Advancements vs Ethics – How to safely use advanced technologies and avoid a catastrophe Synopsis: Technology is advancing exponentially especially with significant progress in Artificial Intelligence, Machine Learning, and Generative AI. But with the advancement comes challenges because technology often outpaces...
How to be agile in the dynamic regulatory environment without sacrificing quality - Best practices for CLIA lab setup and certification The Clinical Laboratory Improvement Amendments require that clinical laboratories, including those in healthcare facilities, reference labs, public health labs, and some research labs need...
From Discovery to Market: Decoding Drug Development's Journey What are the Key Milestones, Challenges, and Innovations in the intricate development process? This webinar provides an insightful view of the intricate process involved in developing pharmaceutical drugs and delves into the multifaceted stages shaping the landscape...
JOIN US FOR AN OCRA OPEN HOUSE - NEW DATE & LOCATION Network, Engage, and Socialize February 26, 2024 5:00 PM - 9:00 PM Program: Introduce the 2024 Board Volunteers & strategic partners appreciation Membership appreciation Membership drive Location: Location: "Be Good" restaurant in Huntington...
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 &...
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 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...
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 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...
IDE Submission Best Practice, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives Date: Thursday, May 30, 2024 (New Date!) Time: 5:30pm – 7:30pm PT Audience: Regulatory and clinical affairs professionals in medical device industry Location: Alcon Laboratories, 20511 Lake Forest Dr, Lake...
China 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 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...
Social 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!
See https://ocra-dg.org/2024-annual-conference/ for event details!
Navigating 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...
Early Registration until 31 May 2024 at 11:59 pm EST. Early Registration rate is $2,785 for non-RAPS Members and $2,205 for RAPS Members. OCRA Members receive 10% off RAPS Convergence registration rate! Contact Membership@ocra-dg.org to obtain the special promo code!
Inherently Safer Design Date: Monday, October 14, 2024 Time: 12pm – 1:15m PT Audience: - Medical device and IVD regulatory affairs professionals - Risk Management professionals - Systems Engineers - Engineering management and design engineers - Clinical Affairs professionals Platform: Zoom Control of risk is...
Clinical Trial Management in Academic Medical Centers Date: Wednesday, October 30 Time: 12:00pm-1:00pm PT Audience: Audiences interested in clinical trial management. Platform: Zoom Clinical trials are crucial for the development of safe and effective medical products and enhancing the quality of patient care worldwide. Effective...
