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...
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?...
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...
FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device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...
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...
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...
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,...
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 &...
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...
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...
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...
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...
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....
JOIN TEAM OCRA FOR THE RELAY FOR LIFE Date: Saturday, Sep 9, 2023 Time: Team OCRA will meet at 9:30am, walk starts at 10am Location: Team OCRA will meet in the parking lot at Santa Ana College, 1530 W. 17th St, Santa Ana As part...
Date: Thursday, Aug 10, 2023 Time: 5-7pm PST Location: Taco Rosa Newport Beach Cost: free Parking: free Finger food is provided, cash bar Contact: fawnzhang0@gmail.com Please join us to learn more about the volunteer opportunities at OCRA! Join the Annual Meeting committee and celebrate OCRA's 30...
OCRA & PDA Co-Hosted Event Date: Thursday, July 27, 2023 Time: 5-8pm PST Location: Tustin Ranch Golf Club Speaker: Dr. Binh Nguyen, Former FDA Official Cost: $25 member, $50 non-member Parking: free REGISTER NOW **PLEASE NOTE** This presentation will be dealing primarily with the...
Hosted Event: This event is brought to you by OCRA and Device Alliance Date: May 25 from 5:30pm - 7:30pm Location: Taco Rosa 2632 San Miguel Dr, Newport Beach, CA 92660 https://www.tacorosa.com/ COST: OCRA or DA members free Non-member $25 online or $30 at the door...
