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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250806T120000
DTEND;TZID=America/Los_Angeles:20250806T130000
DTSTAMP:20260421T025508
CREATED:20250701T063812Z
LAST-MODIFIED:20250701T065141Z
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SUMMARY:Webinar Series - A.I. in Regulatory Affairs
DESCRIPTION:Date: Wednesday | August 6\, 2025 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: Free for OCRA-DG members and nonmembers  \nSpeaker: Kamayani Gupta\, CEO\, KAMI Think Tank \nRegister Now \n  \n\nKamayani Gupta is a life sciences expert who uses data-centric approaches to optimize complex business processes. Over the past decade\, she has enjoyed working with new technologies to reduce redundant workflows and biases in the drug discovery to commercialization pipeline. She was one of the first members of Watson for Drug Discovery\, and the former Head of HCLS R&D at Slalom.
URL:https://ocra-dg.org/event/webinar-series-a-i-in-regulatory-affairs/
LOCATION:Webinar
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250506T120000
DTEND;TZID=America/Los_Angeles:20250506T130000
DTSTAMP:20260421T025508
CREATED:20250409T222201Z
LAST-MODIFIED:20250415T002859Z
UID:31335-1746532800-1746536400@ocra-dg.org
SUMMARY:NAVIGATING THE CURRENT REGULATORY CHANGES IN THE EUROPEAN MEDICAL DEVICE INDUSTRY
DESCRIPTION:Date: Tuesday | May 6\, 2025\nTime: 12 noon to 1pm PT\nLocation: Zoom\nRegistration: Free for OCRA-DG members and nonmembers\nSpeaker: Mizanu Kebede\, Chief Quality & Regulatory Officer Smith & Nephew \nRegister Now
URL:https://ocra-dg.org/event/navigating-the-current-regulatory-changes-in-the-european-medical-device-industry/
LOCATION:Webinar
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250402T183000
DTEND;TZID=America/Los_Angeles:20250402T200000
DTSTAMP:20260421T025508
CREATED:20250315T221307Z
LAST-MODIFIED:20250317T054649Z
UID:31105-1743618600-1743624000@ocra-dg.org
SUMMARY:April 2 - OCRA Career Panel
DESCRIPTION:Join us for the “Navigating Your Path: OCRA Career Panel in Regulatory Affairs“\, an engaging online workshop designed to illuminate the diverse career paths within the regulatory affairs field. Whether you’re a university student\, a healthcare professional looking to transition into regulatory affairs\, or a regulatory affairs professional seeking career growth and new opportunities\, this event is tailored for you! \nOur esteemed panelists\, with backgrounds spanning drugs\, medical devices\, and biologics\, will share their unique career journeys and provide invaluable guidance on job hunting\, interviewing\, and transitioning into regulatory affairs. Gain insights into career development strategies and learn how to achieve long-term success in this dynamic field. \nDon’t miss this opportunity to connect with industry experts\, ask your burning questions\, and take the next step in your regulatory affairs career. Secure your spot today and start navigating your path to success! \n  \nPanel\n \nJulie Manchester\, RAC\, VP\, Regulatory Affairs & Quality at Autonomix Medical \nMs. Manchester is a Biotech/Med Device executive with over 15 years of quality and regulatory experience within the medical device\, cosmetics\, pharmaceutical\, and product testing industries. \nhttps://www.linkedin.com/in/juliemanchester \n  \nJulie will share with us: \n\nCareer Journey: Transitioning from a chemist and quality manager in laboratories to leadership role in medical device quality and regulatory affairs.\nKey Challenges: Overcoming obstacles when moving from laboratory work to quality and regulatory affairs\, and the transferable skills that helped.\nExpectations for Juniors: Essential qualities\, skills\, and attributes sought when hiring and mentoring junior regulatory professionals.\nCareer Growth Strategies: Practical advice for advancing in regulatory affairs\, including promotions and career transitions to find the best fit.\n\n\n  \n \nShepard Bentley\, RAC\, Principal Consultant at Bentley Biomedical Consulting LLC \nShep Bentley is a regulatory affairs consultant with 20+ years’ experience providing regulatory clearances and approvals for devices\, drugs and combination products. Offices and affiliations across United States\, Canada\, Europe\, Brazil and Asia. \nhttps://www.linkedin.com/in/shep-bentley-29939a2 \n  \nShepard will share with us: \n\nTechnology Transition Experience: Insights on translating early-stage university innovations to real-world products and the role of regulatory affairs in this process.\nRegulatory Experience: Key differences and similarities across pharma\, biotech\, and medical devices regulatory affair\, and considerations for choosing companies and fields early in your career.\nEmerging Opportunities & Trends: Insights into new and evolving career opportunities in regulatory affairs driven by technological innovation.\n\n  \n\n  \n \nPaula Lengerke Diaz\, MD\, Regulatory Manager at 4D Molecular Therapeutics  \nPaula Lengerke Diaz is a Regulatory Manager at 4D Therapeutics\, a clinical-stage biopharma company developing genetic medicines for rare diseases. Trained as a medical doctor in Colombia\, she previously served as a Hematology & Oncology Research Fellow at Mayo Clinic and was an associate member at an angel investment firm. Her diverse background bridges medicine\, research\, and regulatory strategy in the biopharma industry. \nhttps://www.linkedin.com/in/paulalengerke \nPaula will share with us: \n\nCareer Journey: Transition from medical doctor\, academic researcher to regulatory affairs\, leveraging academic and clinical experience.\nCurrent Job Sharing: Sharing experience as a regulatory manager in the genetic therapy field\, overseeing clinical trials and crafting regulatory strategies.\nJob hunting Advice: Job hunting tips\, breaking into regulatory affairs\, networking strategies\, and advice for students and professionals in clinical field exploring alternative careers.\n\n  \n\n  \n \nNora Xi\, MS\, Regulatory Affair Associate Specialist at Applied Medical  \nNora Xi is a Regulatory Affairs Associate Specialist at Applied Medical with 2.5 years of experience in the medical device industry. She holds an M.S. in Regulatory Science from the University of Southern California and a B.S. in Biomedical Engineering from City University of Hong Kong. \nhttps://www.linkedin.com/in/nora-xi-7aa469197 \nNora will share with us: \n\nLanding first regulatory affair job as an International Student – how to overcome language and job sponsorship challenges.\nJob Hunting & Interview Success – Resume\, interviews\, and LinkedIn tips for securing internship and full-time jobs in regulatory affair field.\nThe Power of Networking – How to network and get involved in professional organizations for long-term career growth.\n\n\n  \nDate: Wednesday | April 2\, 2025 \nTime: 6:30pm – 8pm PT \nLocation: Zoom \nRegistration: Free for OCRA-DG members and nonmembers \nTopic: OCRA Career Panel \nRegister Now \n 
URL:https://ocra-dg.org/event/april-2-ocra-career-panel/
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250320T120000
DTEND;TZID=America/Los_Angeles:20250320T130000
DTSTAMP:20260421T025508
CREATED:20250224T022107Z
LAST-MODIFIED:20250304T191723Z
UID:30971-1742472000-1742475600@ocra-dg.org
SUMMARY:Webinar Series - Pediatric Drug Labels
DESCRIPTION:Date: Thursday | March 20\, 2025 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: \nRegistration: Free for OCRA-DG members and nonmembers \nSpeaker: Dr. Christopher Landon\, President of Landon Pediatric Foundation \nRegister Now \n  \n\n  \nDr. Chris Landon\, MD\, is a renowned pediatric pulmonologist and innovative researcher with over 40 years of experience in advancing respiratory care. He earned a B.S. in Psychobiology from UC Riverside and an M.D. from USC Keck School of Medicine. Following his residency at Stanford University Hospital and a fellowship in Allergy\, Immunology\, and Respiratory Medicine at Children’s Hospital at Stanford\, he further refined his expertise with a Global Health certificate from Harvard University. His publications span telemedicine\, remote patient monitoring\, COPD and asthma management\, pediatric sleep apnea\, and the integration of artificial intelligence and blockchain in healthcare.
URL:https://ocra-dg.org/event/pediatric-drug-series/
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250313T120000
DTEND;TZID=America/Los_Angeles:20250313T130000
DTSTAMP:20260421T025508
CREATED:20250223T203815Z
LAST-MODIFIED:20250304T191615Z
UID:30961-1741867200-1741870800@ocra-dg.org
SUMMARY:Webinar Series - Decentralized Clinical Trials
DESCRIPTION:Date: Thursday | March 13\, 2025 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: \nRegistration: Free for OCRA-DG members and nonmembers \nSpeaker: Wendi Lau\, DRSc\, Senior Director of Clinical Development Operations at AbbVie Inc. \nRegister Now \n  \n\n  \nWe are thrilled to announce Wendi Lau\, Senior Director of Clinical Development Operations at AbbVie Inc.\, as one of our esteemed speakers! \nWith 30+ years of experience in clinical research\, Wendi has contributed significantly to clinical trial operations\, data management\, and medical writing. Her impressive academic background includes: \n\nB.S in Chemistry (University of Illinois)\nM.S. in Biology (Northeastern Illinois University)\nDoctorate in Regulatory Science (USC)\, where her thesis examined decentralized clinical trials\n\nIn addition to her work at AbbVie\, Wendi is a lecturer at USC\, helping to shape the next generation of clinical research professionals.\nJoin us at the seminar to hear Wendi’s invaluable insights into the future of clinical trials and the evolving landscape of decentralized studies! \nLearning Objectives: \n\nNew FDA regulations and changes\nImpact of AI on MDR\nPathways for Pre-IND and much more!
URL:https://ocra-dg.org/event/decentralized-clinical-trials/
CATEGORIES:Events,Networking,OCRA Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240912T120000
DTEND;TZID=America/Los_Angeles:20240912T131500
DTSTAMP:20260421T025508
CREATED:20240827T060539Z
LAST-MODIFIED:20240828T054722Z
UID:30236-1726142400-1726146900@ocra-dg.org
SUMMARY:Navigating EU MDR Compliance for CE Marking
DESCRIPTION:Navigating EU MDR Compliance for CE Marking \nDate: Thursday\, September 12\nTime: 12pm-1:15pm PT\nAudience: This webinar is recommended for professionals with some familiarity with EU MDR or the previous Medical Device Directive (MDD).\nPlatform: Zoom \nThis webinar aims to provide an overall understanding of the critical aspects of EU MDR compliance. Whether you’re preparing for the application (deadline is coming up!) or looking to enhance your knowledge\, this session is designed to equip you with the necessary insights. \nKey Topics to be Covered:\n– EUDAMED and Quality Management System requirements under EU MDR\n– Technical documentation requirements for a CE marking submission and how to avoid common pitfalls\n– Post-market lifecycle management and reporting \nProgram Synopsis:\nRegulation (EU) 2017/745 (“EU MDR”) has been in force since May 2021\, requiring manufacturers of legacy devices to update their quality management systems (QMS) and technical documentation. This webinar will provide a detailed overview of the steps necessary for a successful transition to EU MDR and CE marking. Key topics include interactions with Notified Bodies\, project planning\, EUDAMED implementation\, and QMS and technical documentation requirements\, both pre- and post-approval. \nWith a special focus on the upgrade of legacy devices to MDR\, our expert\, Dr. Artemis Ailianou\, will share case studies and real-life scenarios to illustrate practical strategies and tactics. This will be an invaluable session for anyone looking to understand the intricacies of EU MDR compliance and avoid common pitfalls. \nLearning Objectives:\nGain a clear understanding of EUDAMED and QMS requirements under EU MDR.\nLearn about technical documentation requirements for CE marking submissions.\nUnderstand the essentials of post-market lifecycle management and reporting.\nDon’t miss this opportunity to enhance your knowledge and stay ahead in the ever-evolving regulatory landscape! \n  \n\n\nAbout the Speaker:\n  \nArtemis Ailianou\, PhD\, MBA\, President\, ARTIA RA/QA Consulting Inc \nDr Ailianou is a regulatory affairs and quality system consultant specializing in CE marking and clinical trial applications. She previously worked for a European startup in the ophthalmic space where she led CE marking submission activities for Class IIb implantable devices\, approved in 2021 and 2023. She has also managed clinical trial applications in Europe\, Canada\, and US\, securing approvals from competent authorities and ethics committees. Prior to her career in regulatory affairs\, she worked in product R&D for novel polymeric materials. Dr. Ailianou earned her BSc in Chemical Engineering from the University of Texas at Austin; her PhD\, also in Chemical Engineering\, from California Institute of Technology; and her MBA from INSEAD in France. \n\n  \nFree for Member\n$20 for Nonmember \nRegister Now! \nRegistering for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n  \n \n  \n \n  \n  \n  \n \n  \n          \n  \n  \n  \n       \n  \n                                   
URL:https://ocra-dg.org/event/navigating-eu-mdr-compliance-for-ce-marking/
LOCATION:Online
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240712T160000
DTEND;TZID=America/Los_Angeles:20240712T200000
DTSTAMP:20260421T025508
CREATED:20240608T194037Z
LAST-MODIFIED:20240630T164541Z
UID:29800-1720800000-1720814400@ocra-dg.org
SUMMARY:Summer Social
DESCRIPTION:Social Summer \nDate: Friday\, July 12\, 2024\nTime: 4 – 8pm PT\nLocation: Bosscat Kitchen & Libations\n18169 Von Karman Ave\, Irvine\, CA 92612 \n  \nFree for Member\n$10 for Nonmember \nRegister Now! \n 
URL:https://ocra-dg.org/event/summer-social/
LOCATION:Bosscat Kitchen & Libations\, 8169 Von Karman Ave\,\, Irvine\, CA\, 92612\, United States
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240626T120000
DTEND;TZID=America/Los_Angeles:20240626T130000
DTSTAMP:20260421T025508
CREATED:20240521T052609Z
LAST-MODIFIED:20240622T081446Z
UID:29309-1719403200-1719406800@ocra-dg.org
SUMMARY:What's New in FDA 510(k) & eSTAR Best Practice
DESCRIPTION:What’s New in FDA 510(k) & eSTAR Best Practice \nDate: Wednesday\, June 26\, 2024\nTime: 12 noon – 1pm PT\nAudience: Medical device regulatory affairs professionals who are involved in the 510(k) submission process.\nPlatform: Zoom \nThe panel will provide an overview of the recent updates and changes in FDA 510(k) program and guide the participants through best practices for preparing a 510(k) submission in the eSTAR system and share useful tips through case scenarios. \nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nUnderstand the recent updates and changes in FDA 510(k) program\nLearn best practices for submitting 510(k) applications in the eSTAR system\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nHeather Rosecrans\, F.R.A.P.S.\, EVP\, Medical Devices & Combination Products at Eliquent Life Sciences\n \nHeather boasts over 45 years of public health and medical device expertise. Formerly the Director of the 510(k) Premarket Notification Staff at the FDA CDRH\, she spearheaded regulatory policy implementation and led key programs. Heather’s significant contributions include drafting guidance documents and regulations of the 510(k)\, training FDA staff and other stakeholders\, and shaping pivotal legislation. Her unparalleled experience has established her as a foremost expert in FDA 510(k) processes. With a B.S. in biology from Pfeiffer College\, Heather now leverages her knowledge to consult and facilitate innovative device entry into the U.S. \n  \nSamantha Eakes\, MPH\, VP\, Regulatory Affairs at Eliquent Life Sciences\n \nSamantha brings over seven years of FDA regulatory consulting experience. With a background in public health\, policy\, and nonprofits\, she offers strategic insight into regulatory challenges. Her expertise spans various FDA submissions\, including 510(k) Premarket Notifications and Emergency Use Authorizations. Samantha has published articles on medical device topics and previously contributed to policy and advocacy at Management Sciences for Health. She holds a B.A. in psychology and an M.P.H. from Boston University. \n  \n\n  \nFree for Member\n$20 for Nonmember \nRegister Now! \nRegistering for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n \n  \n  \n  \n  \n  \n  \n  \n \n  \n                          
URL:https://ocra-dg.org/event/whats-new-fda-510k-estar-best-practice/
LOCATION:Online
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240606T080000
DTEND;TZID=America/Los_Angeles:20240606T090000
DTSTAMP:20260421T025508
CREATED:20240404T044408Z
LAST-MODIFIED:20240516T065820Z
UID:29012-1717660800-1717664400@ocra-dg.org
SUMMARY:China Medical Device Registration Clinical Pathways Latest Updates
DESCRIPTION:China Medical Device Registration Clinical Pathways Latest Updates \nDate: Wednesday\, June 6\, 2024\nTime: 8am – 9am PT\nAudience: Regulatory and clinical professionals in medical device industry\nPlatform: Zoom \nStruggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence? Is clinical trial needed to support your device registration in China? \nThis webinar provides an overview of the critical elements of China’s registration and clinical pathways\, focusing on the China regulatory and clinical framework and finds the least burdensome pathway with the latest China NMPA (National Medical Products Administration) updates.\nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nOverview of key pathways for medical device and IVD registration\nExplore the clinical evaluation requirement for product registration in China\nLearn about the key requirements and criteria to determine the different clinical pathways\nUnderstand the role of RWE in clinical evidence to support product registration\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nGrace Fu Palma\, Principal at China Med Device\, LLC/Accel Groups \nGrace spearheads China Med Device\, a sector of Accel Groups\, streamlining market access for medical device firms. With three decades’ experience in global business strategy\, regulatory affairs\, and clinical trials\, she’s bilingual and a recognized expert in China and US MedTech. She’s also founded the Chinese American Heart Association\, strengthening connections between clinical communities in the US and China. A member of prominent physician communities like ANACP and CAP\, Grace is deeply entrenched in clinical networks bridging the US and China. Raised in Beijing\, she holds a BA/BS from Peking University and an MBA from Yale University. \n  \nYan Sheng\, PhD\, Project Manager at China Med Device\, LLC/Accel Groups\n \nYan has extensive experience in the life science industry\, having worked in both the United States and China. With over four years as a project manager at China Med Device/Accel Groups\, her expertise extends to a diverse range of areas\, including IVD and CDx products\, combination products\, as well as medical devices such as implants\, aesthetics devices\, etc. Yan holds a PhD degree in Pharmaceutical Sciences and has a rich history of working with cutting-edge technologies in the realms of both chemistry and microbiology prior to her entry into the life science industry. \n  \n\n  \nFree for Member\n$20 for Nonmember \nRegister Now! \nRegistering for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nThank you to our Sponsors!\n  \n  \n  \n  \n  \n  \n             
URL:https://ocra-dg.org/event/china-medical-devices-updates/
LOCATION:Online
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240522T120000
DTEND;TZID=America/Los_Angeles:20240522T130000
DTSTAMP:20260421T025508
CREATED:20240221T193357Z
LAST-MODIFIED:20240508T052647Z
UID:28020-1716379200-1716382800@ocra-dg.org
SUMMARY:FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance
DESCRIPTION:FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance \nDate: Wednesday\, May 22\, 2024\nTime: 12pm – 1pm PT\nAudience: Medical device quality assurance\, regulatory affairs\, and R&D leaders and practitioners.\nPlatform: Zoom \nIn April 2023 FDA published its Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance\, and FDA has been actively reviewing PCCPs in submission prior to and since the publication of this document. This session will walk through the contents of the draft guidance highlighting specific recommendations\, implications to industry and FDA\, and how this guidance might help or hinder an effective regulatory framework for incorporating AI/ML functionality into medical devices. \nLearning Objectives: \n\nUnderstanding the requirements of FDA’s PCCP for AI/ML draft guidance\nUnderstanding of the implications of PCCPs for AI/ML-enabled product modifications and submissions\nHow the draft guidance may impact FDA’s efforts to establish a regulatory framework for AI/ML-enabled medical devices\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speaker:\n \nEric Henry\, Sr. Quality Systems & Compliance Advisor at King & Spalding LLP\n \nEric is a Senior Quality Systems and Compliance Advisor in the FDA & Life Sciences Practice of the law firm King & Spalding.  He is a 35-year industry veteran and since 2018 has provided advisory and consulting services focused on regulatory compliance\, enforcement\, and policy matters for industries regulated by the FDA. Eric’s guidance focuses on FDA requirements to professionals in medical device manufacturing\, including but not limited to quality systems requirements\, inspection preparedness and post-market obligations. He also advises corporate management and boards on their responsibilities and expectations of the FDA. \n  \n  \n\n  \nFree to Members\n$20 for Nonmembers \nRegister Now! \nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\n  \nOCRA Gold Sponsors:
URL:https://ocra-dg.org/event/fda-pccp/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240415T160000
DTEND;TZID=America/Los_Angeles:20240415T170000
DTSTAMP:20260421T025508
CREATED:20240221T193245Z
LAST-MODIFIED:20240321T215844Z
UID:28018-1713196800-1713200400@ocra-dg.org
SUMMARY:Quality System Audit Best Practice\, Tips & Tricks for Finding Mitigation
DESCRIPTION:Mastering QMS Audit Readiness: Strategies for Preparation\, Conduct\, and Mitigation\nMastering QMS Audit Readiness: Strategies for Preparation\, Conduct\, and Mitigation Webinar \nJoin us for an insightful webinar where we’ll delve into comprehensive strategies and tactics to help ensure your organization is prepared for your next audit. \nDate: Monday\, April 15\, 2024\nTime: 4pm to 5pm PT\nPlatform: Zoom \nIn this dynamic session\, our expert speaker will guide you through the entire audit lifecycle\, covering crucial aspects such as: \n\n Pre-Audit Preparation: Gain actionable insights into preparing your facility and personnel for a successful quality system audit. Learn how to ensure readiness\, establish best practices\, and optimize cross-functional team collaboration to streamline audit preparations.\n Front Room and Back Room Management: Discover effective strategies for managing interactions with auditors (front room) and coordinating behind-the-scenes operations (back room) during the audit process. From responding to inquiries to retrieving requested documents\, you’ll learn how to maintain professionalism and efficiency throughout.\n Audit Finding Mitigation: Explore proactive approaches to mitigate audit findings and enhance audit outcomes. Learn how to identify potential issues\, address auditor questions with confidence\, and implement strategies that helps to mitigate/de-escalate findings and observations. The speaker will share real-life cases and scenarios to facilitate your understanding.\n\nThis webinar is essential for Quality & Regulatory Directors and Managers\, Quality & Regulatory personnel supporting a QMS audit\, as well as any job functions that are involved in a QMS audit. Don’t miss this opportunity to gain invaluable insights and actionable strategies to elevate your organization’s audit readiness and effectiveness. \nRegister now to secure your spot and empower your team for audit success! \nAbout the Speaker:\nJulie Manchester\, Senior Director Quality Assurance & Regulatory Affairs\, The HydraFacial Company \nJulie Manchester is a seasoned leader with over 15 years of experience in quality and regulatory affairs across biotech\, medical devices\, pharmaceuticals\, and other industries. Holding a Bachelor of Science from UC Riverside\, she is an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and holds a RAPS Device certification. Julie is deeply engaged in community and industry leadership roles\, serving as committee members for OCRA\, RAPS\, and ASQ\, contributing to industry standards and best practices. She also serves the board of the VietNam Scholarship Foundation\, and as an Advisory Committee Member for the Women of Leadership Program at the University of Richmond. Throughout her career\, Julie has excelled in building\, leading\, and executing quality management and regulatory programs\, ensuring adherence to quality standards and regulatory compliance in international markets\, and has hosted over 250 audits including regulatory body audits and inspections\, such as the FDA and Notified Bodies\, technical/safety audits\, customer audits and more. \nRegister Now! \nFree to OCRA member\n$20 for nonmember\nRegister for your team of 5+ participants? Please email programs@ocra-dg.org. \n\nThank you to our Silver Sponsors!
URL:https://ocra-dg.org/event/quality-system-audit-best-practice-tips-tricks-for-finding-mitigation/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240409T180000
DTEND;TZID=America/Los_Angeles:20240409T200000
DTSTAMP:20260421T025508
CREATED:20240221T193125Z
LAST-MODIFIED:20240404T044955Z
UID:28017-1712685600-1712692800@ocra-dg.org
SUMMARY:Job Interview Virtual Workshop
DESCRIPTION:Job Interview Techniques & Practical Role-playing with Industry Experts\nJoin 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 on interview preparation\, learn the dos and don’ts\, and uncover strategies for standing out in a competitive job market. \nThe highlight of this virtual event is the interactive mock interview session. Participants will have the opportunity to engage in role-play scenarios\, simulating responses to real-world interview questions in breakout rooms facilitated by industry experts. \nThis hands-on experience allows participants to refine their interview skills\, receive personalized feedback\, and build confidence for their upcoming job interviews in the relevant fields. \nParticipants must turn on their camera and microphone for the mock interview session. \n  \nPanel: \nSara Yazdanfar\, Scientific Recruiting Team Lead at Applied Medical \nSara Yazdanfar has been in the recruiting field for 5 years. Currently\, Sara is the Scientific Recruiting Team Lead at Applied Medical\, a rapidly growing global organization with approximately 5\,000 team members. Sara studied at USC in her Master’s in Applied Psychology\, emphasis in Organizational Psychology. Her joy in life is connecting with people\, learning about their experiences\, and hopefully\, finding the right career for them\, and supporting them through the process! \n  \n  \nRichard DeRisio\, Training Program Developer and Presenter at DeRisio Group\, LLC \nRichard DeRisio is a seasoned professional in regulatory affairs and quality systems\, with a wealth of experience in the pharmaceuticals\, diagnostics\, and medical devices industries. Beginning his career at the FDA’s Washington-area headquarters\, Richard managed foreign inspections\, conducted compliance actions\, and served as an expert in sterilization sciences. Throughout his career\, he has held leadership positions at major companies including Abbott\, J&J\, Covidien\, and Pfizer\, overseeing global and divisional clinical\, quality\, regulatory\, government affairs\, and operations functions. Richard also led the Americas Region for the German Notified Body TÜV SÜD\, responsible for CE-Mark approval of medical devices manufactured in North America. He holds a B.S. degree in chemical engineering and an M.S. degree in food science and technology from Cornell University. Richard has been actively involved in industry organizations\, serving on the Association for the Advancement of Medical Instrumentation Board of Directors and co-chairing multiple standards committees. He has presented at regulatory programs at USC and Chapman University\, published in Medical Device & Diagnostic Industry magazine\, and spoken at UBM/Canon Medical Design and Manufacturing Conferences\, among others. \n  \nRonald Kao\, Principal Recruitment Consultant\, Real Staffing \nRonald is a seasoned Principal Recruitment Consultant based in San Diego\, who focuses on Direct-Hire placement within the Medical Device and Diagnostic industry across the West Coast. He has over 5 years of recruiting experience placing and consulting with executives\, senior leadership\, and senior/principal level professionals. Having a degree in psychology and social behavior\, Ronald has a strong ability to understand people and uses that to connect them to their dream jobs and opportunities. A tennis\, yoga\, and escape room enthusiast\, he is driven by bringing skilled people together to create a win-win situation. \n  \nHuong Huynh\, PhD\, Director of Regulatory Science at Critical Path Institute \nHuong Huynh\, PhD is Director of Regulatory Science at Critical Path Institute (C-Path) and Professor of Practice at The University of Arizona James E. Rogers College of Law. At C-Path\, Huong leads the development of regulatory strategies for the organization and bridges communication with regulatory authorities; she has contributed to the standup of 3 new public-private partnerships to address rare neurodegenerative diseases and for research on unmet medical needs in alpha-1 antitrypsin deficiency and lysosomal diseases. At The University of Arizona\, Huong is a lead instructor as part of the Graduate Certificate in Regulatory Science. Prior to joining C-Path\, Huong was a review pharmacologist at FDA\, where she contributed to the assessment of the approvability of over 300 regulatory submissions\, leading to the approval of over 50 generic drug products. \n  \nDate: Tuesday\, April 9th \nTime: 6pm to 8pm \nCost: $10 Members – $20 Non-members \nMembers: be sure to log in to get the member discount! \nNote: Space is limited in order to maintain a good interviewer-interviewee ratio. We respectfully ask you to email programs@ocra-dg.org at least 3 days in advance if you cannot attend the event so the space can be released to others on the waitlist. Priorities will be given to OCRA members. \nRegister Now! \n\nThank you to our Silver Sponsors!
URL:https://ocra-dg.org/event/regulatory-affairs-job-interview-prep-mock-interview/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240328T120000
DTEND;TZID=America/Los_Angeles:20240328T130000
DTSTAMP:20260421T025508
CREATED:20240221T193018Z
LAST-MODIFIED:20240321T215938Z
UID:28016-1711627200-1711630800@ocra-dg.org
SUMMARY:Artificial Intelligence in Drug Development
DESCRIPTION:Date: Thursday | March 28\, 2024 \nTime: 12 noon to 1pm PT \nLocation: Zoom \nRegistration: Free for OCRA-DG members; $20 for nonmembers \nArtificial intelligence (AI) and machine learning (ML) technologies have the potential to advance drug development in multiple areas\, including candidate identification and refinement\, nonclinical and clinical research\, manufacturing\, and post market surveillance. The Food and Drug Administration (FDA) has recognized this potential\, and is actively seeking feedback and engagement from stakeholders in this area as the agency works towards building a regulatory framework.  In this program\, we will review FDA’s current thinking on the use of artificial intelligence and machine learning in drug development\, and explore ways in which drug companies are using these technologies to improve their business. \nLearning Objectives: \n\nUnderstanding of FDA’s current thinking on the use of artificial intelligence and machine learning in drug development\nExamples of ways in which drug companies are using artificial intelligence and machine learning to improve their business\n\nWho Should Attend: \n\nPharmaceutical regulatory affairs professional\nPharmaceutical executives\, entrepreneurs\, and business owners\nAnyone keen on the future of healthcare innovation!\n\nRegister Now! \n\nAbout the Speaker: \n  \n \nBert Lao\, JD\, PhD\nCounsel\, Hogan Lovells \nBert Lao\, JD\, PhD\, serves as Counsel at Hogan Lovells\, bringing over a decade of experience in pharmaceutical law. His expertise lies in assisting drug companies in navigating regulatory requirements and legal challenges. Throughout his career\, he has provided guidance to clients across various stages of product development\, including clinical trials\, FDA interactions\, and approval processes. \nIn addition to his involvement in product development\, Bert supports drug companies in maintaining regulatory compliance and addressing legal issues. His services encompass a range of activities such as assisting with securities filings\, conducting internal investigations\, drafting trade complaint letters\, and reviewing promotional materials for pharmaceuticals\, over-the-counter drugs\, and cosmetics. \nBert Lao holds a JD from UC Berkeley School of Law and a PhD in Biomedical Engineering from UCLA. \n  \n  \n  \n  \n\n\nThank you to our Silver Sponsors!
URL:https://ocra-dg.org/event/artificial-intelligence-in-drug-development/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240311T160000
DTEND;TZID=America/Los_Angeles:20240311T170000
DTSTAMP:20260421T025508
CREATED:20230228T162106Z
LAST-MODIFIED:20240305T152827Z
UID:27145-1710172800-1710176400@ocra-dg.org
SUMMARY:Overview of China NMPA and Pharmaceutical GMP Regulations
DESCRIPTION: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. \nSpeaker: Andrew Chen\, J.D. \nChief Representative\, Shanghai Office of Arnold & Porter LLP. Mr. Chen is a seasoned expert with over two decades of experience\, including serving at the US FDA and Amgen. \n \nIn this webinar\, you can expect to learn about: \n\nThe NMPA as a government agency.\nChinese approach to drug approval and oversight.\nChinese pharmaceutical GMP regulations.\n\nDuring the presentation\, the speaker will draw comparisons between China’s NMPA and the US FDA\, aiming to enhance comprehension for individuals familiar with the US FDA. With the speaker’s distinctive expertise in both US and Chinese law\, he has the capacity to distill complex topics into a simple\, organized\, and easily understandable presentation. \nWho Should Attend: \n\nPharmaceutical professionals whose job responsibilities or professional interests involve China.\nPharmaceutical professionals in RA\, QA\, medical\, commercial\, business development\, and legal functions.\nPharmaceutical professionals at all levels of experience\, from entry to executive levels.\n\nRegister Now!
URL:https://ocra-dg.org/event/china-nmpa/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240305T180000
DTEND;TZID=America/Los_Angeles:20240305T191500
DTSTAMP:20260421T025508
CREATED:20230228T162147Z
LAST-MODIFIED:20240221T193648Z
UID:27146-1709661600-1709666100@ocra-dg.org
SUMMARY:OCRA/USC Joint Career Program: Landing Your First Job in Regulatory Affairs
DESCRIPTION:
URL:https://ocra-dg.org/event/ocra-usc-joint-career-program/
CATEGORIES:Joint Meetings,Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240220T160000
DTEND;TZID=America/Los_Angeles:20240220T170000
DTSTAMP:20260421T025508
CREATED:20240207T210455Z
LAST-MODIFIED:20240208T165759Z
UID:27975-1708444800-1708448400@ocra-dg.org
SUMMARY:Webinar: Drug Development Overview
DESCRIPTION:From Discovery to Market: Decoding Drug Development’s Journey\n\n\n\n\n\n\n\nWhat are the Key Milestones\, Challenges\, and Innovations in the intricate development process? \nThis webinar provides an insightful view of the intricate process involved in developing pharmaceutical drugs and delves into the multifaceted stages shaping the landscape of modern medicine. From initial discovery to market launch\, this presentation will take you on a journey through key milestones\, challenges\, and innovations that define the pharmaceutical industry today. \nDate: Tue\, Feb 20\, 2024 \nTime: 4:00 PM- 5:00 PM PT \nLocation: Zoom \nRegistration: Free for OCRA members\, $20 for nonmembers \nThis presentation will use the real-world case scenario approach to provide a look at the drug development process\, covering:  \n\nDrug Discovery Milestones: Understand the critical importance of milestones in drug discovery.\nNonclinical Testing: How nonclinical testing lays the groundwork for successful drug development\, ensuring safety and efficacy are at the forefront.\nChemistry\, Manufacturing\, and Controls (CMC): Gain insights into the necessity of a clear understanding of CMC\, a foundational element in the development process that ensures the quality and consistency of pharmaceutical products.\nRegulatory Path for IND Application Submission: Explore innovative approaches to identifying the most successful regulatory path for Investigational New Drug (IND) Application.\nPhases of Clinical Trials: Navigate through the phases of clinical trials\, from initiation to completion\, understanding the challenges and triumphs that accompany each stage.\nNew Drug Application (NDA) and FDA Inspections: Understanding the crucial steps that determine a drug’s eligibility for market launch.\nPost Marketing Requirements: Uncover the ongoing responsibilities that pharmaceutical companies face after a drug is introduced to the market.\n\nWho Should Attend: \n\nRegulatory professionals\nPharmaceutical researchers and scientists\nHealthcare professionals\nStudents and academics\n\nRegister Now! \nAbout the speaker:\nBani Tchekanova\, PhDSVP of Global Regulatory AffairsClinReg PartnersMember of FDA Advisory Committee\n  \n\n\n\n\n\n\n\n  \nDr. Tchekanova has over 25 years of extensive industry expertise spanning diverse therapeutic areas\, including oncology\, dermatology\, infectious disease\, ophthalmology\, cardiovascular\, and neuroscience. A seasoned Strategic Global Regulatory Affairs Professional\, Dr. Tchekanova’s proficiency extends to various pharmaceutical domains such as IND\, NDA\, BLA\, and MAA encompassing CMC\, nonclinical\, clinical\, biologics (BLA)\, medical devices (510k)\, OTC\, and cosmetics. \n  \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nThank you to our platinum Sponsor!
URL:https://ocra-dg.org/event/webinar-drug-development-overview/
CATEGORIES:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230915T120000
DTEND;TZID=America/Los_Angeles:20230915T130000
DTSTAMP:20260421T025508
CREATED:20230906T183726Z
LAST-MODIFIED:20230906T183726Z
UID:27740-1694779200-1694782800@ocra-dg.org
SUMMARY:OCRA Leadership Circle Meeting
DESCRIPTION:The first meeting of the OCRA Leadership Circle will be Friday\, Sept 15th\, from 12:00-1:00pm PT\, via Zoom. \nFor more information\, please contact Huong Huynh at membership@ocra-online.org \nFor Members Only \n  \n\n  \nDo you have mentors\, sponsors\, and allies? Learn about these important supporters to your career journey. \nThe OCRA Leadership Circle is a new initiative for members only with\nan objective of helping develop future regulatory professional leaders and\nmanagers. Our goal is to learn from each other through peer-to-peer learning\,\nto recognize different types of leadership styles\, which leadership style works\nbest for us and how to adapt leadership styles for various situations. \nThe OCRA Leadership Circle is envisioned as a discussion group and will meet monthly to share learnings from short readings (articles or book chapters) or video vignettes\, and how we can each develop and improve our skills to lead people and manage projects.
URL:https://ocra-dg.org/event/ocra-leadership-circle-meeting/
LOCATION:Online
CATEGORIES:OCRA Meetings,Online
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END:VCALENDAR