San Diego Regulatory Affairs Network

??Registration is EXTENDED for our Winter Session! Enrollment for San Diego Regulatory Affairs Network's hashtag #RAC Preparatory Courses is NOW OPEN and YOU are invited to register and join us! Now is the perfect time to join our education community and study for the RAC on your own time. Our pre-recorded sessions allow you to study with brilliant industry leaders at a time that's most convenient for you. ??Registration Link for DEVICES: https://lnkd.in/gdptMWs2 ??Registration Link for DRUGS: https://lnkd.in/gZwXNeTJ The SDRAN RAC Preparatory Sessions are open to SDRAN members only. You must become an SDRAN member before registering for the SDRAN RAC Preparatory Sessions. Join or renew your hashtag #SDRAN membership now at https://lnkd.in/gqRxKR7K!

??Registration is OPEN for our Winter Session! Enrollment for San Diego Regulatory Affairs Network's #RAC Preparatory Courses is NOW OPEN and YOU are invited to register and join us! Now is the perfect time to join our education community and study for the RAC on your own time. Our pre-recorded sessions allow you to study with brilliant industry leaders at a time that's most convenient for you. ??Registration Link for DEVICES: https://lnkd.in/gdptMWs2 ??Registration Link for DRUGS: https://lnkd.in/gZwXNeTJ The SDRAN RAC Preparatory Sessions are open to SDRAN members only. You must become an SDRAN member before registering for the SDRAN RAC Preparatory Sessions. Join or renew your #SDRAN membership now at https://lnkd.in/gqRxKR7K!

Register today for SDRAN's November 2024 In-Person & Virtual Event! What Regulatory Affairs Professionals Need to Know About the New CDRH/CBER Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices: A discussion of potential implications for the medical device industry ?? Registration link: https://lnkd.in/dH5NskTT ??Program Topic: The FDA Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) recently released a long-awaited draft guideline titled, Chemical Analysis for Biocompatibility Assessment of Medical Devices (https://lnkd.in/ehR7zuGZ). As stated in the document, the goal of this draft guidance is to: “describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices.” The draft guidance further states, “The recommendations provided in this guidance are intended to improve consistency and reliability of analytical chemistry studies and are based on FDA’s experience evaluating such studies submitted as part of premarket submissions to demonstrate device biocompatibility.” At the upcoming SDRAN meeting, Ron Brown from the Risk Science Consortium, LLC and Sherry Parker from SParker Toxicology Consulting, LLC will provide a high level overview of the approaches described in the draft guidance and will explore the implications of the proposed changes for the medical device industry. ?? Date: Thursday, November 14, 2024 ? Time: 5:30 PM- 8:00 PM Pacific Time ??Location: Zoom & Neurocrine Biosciences 12790 El Camino Real San Diego, California 92130 (NO registration at the door is allowed.) ??Registration Price: SDRAN members ($20 In-Person, $10 Virtual), for Non-Members ($30 In-Person, $20 Virtual) ?? Program Speakers: Ron Brown, Risk Science Consortium, LLC https://lnkd.in/gNfkYsPg Sherry Parker, SParker Toxicology Consulting, LLC https://lnkd.in/drdFQQz8 Join or renew your #SDRAN membership now at https://lnkd.in/gqRxKR7K! #regulatoryaffairs Your document has finished loading

? Job Opportunity Alert! ? Click the link below to apply. Best of luck to our #SDRAN community!

??Registration is OPEN for our Winter Session! Enrollment for San Diego Regulatory Affairs Network's #RAC Preparatory Courses is NOW OPEN and YOU are invited to register and join us! Now is the perfect time to join our education community and study for the RAC on your own time. Our pre-recorded sessions allow you to study with brilliant industry leaders at a time that's most convenient for you. ??Registration Link for DEVICES: https://lnkd.in/gdptMWs2 ??Registration Link for DRUGS: https://lnkd.in/gZwXNeTJ The SDRAN RAC Preparatory Sessions are open to SDRAN members only. You must become an SDRAN member before registering for the SDRAN RAC Preparatory Sessions. Join or renew your #SDRAN membership now at https://lnkd.in/gqRxKR7K!

Upcoming #OCRA-DG webinar: Inherently Safer Design for Medical Devices ?? Date: Monday, October 14, 2024 ? Time:12:00 PM – 1:15 PM PT ?? Zoom ?? Register: https://lnkd.in/gXc7dghz Join us for an interactive webinar on Inherently Safer Design, based on ISO 14971, the standard for risk management in medical devices. This webinar will offer practical tools and a consistent methodology for implementing inherently safer systems across all phases of design and operation, with a special focus on early-stage development. Learn how to eliminate hazards and reduce the probability of harm, while applying creative solutions to achieve safer and more effective medical devices. ?? Key Takeaways: 1?? Gain an in-depth understanding of designing inherently safer systems. 2?? Learn a proven methodology to lead design teams toward safer solutions. 3?? Discover how to apply these techniques early in the design cycle for maximum impact. About the Speaker: Jerry Valenti, Engineering Consultant at PRN Medical Solutions, with 30+ years of medtech experience in Verification, Design Assurance, Regulatory Review, and Submission. Jerry has extensive expertise in FDA and ISO standards, with a focus on risk management and inherently safer design practices. Don’t miss this opportunity to enhance your knowledge and improve your design process! #MedicalDevices #RiskManagement #RegulatoryAffairs #InherentlySaferDesign #ISO14971 #OCRA-DG #Webinar

?? PSA!! We'll be there at the Regulatory Affairs Professionals Society (RAPS) Convergence 2024! Come see us at Stand number TT-5! Hope to see you there! ?? #SDRAN #RAPS #Convergence #RegulatoryAffairs

?? We want to celebrate YOU, our amazing #SDRAN members! ?? ?? Registration link: https://lnkd.in/g4gf3Mt8 ?? Date: Wednesday, October 9th, 2024 ? Time: 6:00 PM- 9:00 PM Pacific Time ??Location: Cutwater Spirits Tasting Room 9750 Distribution Ave, San Diego, CA 92121 (NO registration at the door is allowed. ?) ??Registration Price: $20 SDRAN members ONLY! This is a perfect opportunity to become a member! Join or renew your #SDRAN membership now at https://lnkd.in/gqRxKR7K!

?? REMOTE Job Opportunity Alert! ?? They are looking for a Senior Director of Regulatory Affairs who has both Clinical Strategy and CMC experience! Take a look at the job description attached & if interested in learning more please Easy Apply or email Conner Harman your resume at [email protected]!

?? The Office of Regulatory Affairs and Quality #ORAQ at Duke University School of Medicine is launching its 2024 Fall Session of the Regulatory Affairs Training Program! ?? This program is #FREE & open to all interested individuals who register. The program provides an overview of premarket regulatory work related to drugs, biologics, and medical devices, covering the following topics: ?? Drug Development and FDA Meetings ?? Applicability of FDA Drug Regulations to Clinical Studies ??IND Content, Format, Review and Maintenance ?? Medical Device Development and FDA Meetings ?? Applicability of FDA Device Regulations to Clinical Studies ??IDE Preparation, Submission, and Maintenance. ??Enrollment for Fall 2024 will open soon. ?? If you are interested in registering, complete the ORAQ Regulatory Affairs Training Program Interest Form linked here: ?? https://lnkd.in/gXDScJpf Want more information? Go to the Duke University Website to learn more! ??https://lnkd.in/e6bYJ9nc #RegulatoryAffairs #TrainingProgram #ContinuousLearning #regulatory #pharmaceuticals #drugdevelopment #dukeedu #clinicalresearch #freeeducation #aspiringRA #dukeuniversity #fdaregulations #medicaldevices #clinicalstudies #tellafriend #sharingknowledge #sharingiscaring