BEGIN:VCALENDAR VERSION:2.0 PRODID:-//OCRA-DG - Regulatory Affairs - ECPv6.11.2.1//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-ORIGINAL-URL:https://ocra-dg.org X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:America/Los_Angeles BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20230312T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20231105T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20240310T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20241103T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20250309T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20251102T090000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20251204T180000 DTEND;TZID=America/Los_Angeles:20251204T200000 DTSTAMP:20260415T204246 CREATED:20251112T012825Z LAST-MODIFIED:20251112T012825Z UID:32023-1764871200-1764878400@ocra-dg.org SUMMARY:Community Holiday Appreciation Dinner - Thursday\, December 4th DESCRIPTION:Date: Dec 4th\, 2025\, Tuesday\nTime: 6:00 pm – 8:00 pm PT\nLocation: Fogo de Chão – 623 Spectrum Center Dr\, Irvine\, CA 92618\nPrice: FREE for Current OCRA-DG Members \nRegister Now URL:https://ocra-dg.org/event/community-holiday-dinner-members-december-4th/ CATEGORIES:Events,In Person END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20251028T123000 DTEND;TZID=America/Los_Angeles:20251028T183000 DTSTAMP:20260415T204246 CREATED:20250711T064858Z LAST-MODIFIED:20251004T033426Z UID:31832-1761654600-1761676200@ocra-dg.org SUMMARY:Fall Symposium - Tuesday\, October 28th DESCRIPTION:Join us for another premier event\, an inspiring symposium focused on best practices\, practical insights\, an meaningful networking opportunities you won’t want to miss. \nCo-Sponsored by IPM\nReception Sponsored by 4C Pharma Solutions\nDate: Oct 28\, 2025\, Tuesday\nTime: 12:30 – 6:30 pm PT\nLocation: University Club: Secret\, Sophisticated Irvine\, CA Wedding Venue\n801 E Peltason Dr\, Irvine\, CA 92617\nDinner: Included\nPrice: $75 non-member\, $50 member and early bird (end Sep 1)\nParking: Free \nRegister Now \n2025 OCRA Fall Symposium Agenda\n\n\n\n\n12:00-1:00\nRegistration\n\n\n\nPharma\nDevice\n\n\n1:00-1:45\nSpeaker: Peder Seglund\, PhD\nTopic: Increasing Efficiencies\nand Reducing Costs by\nImplementing Artificial\nIntelligence and Outsourcing for\nRegulatory Affairs and\nPharmacovigilance\nSpeaker: Heinz Steneberg\nTopic: EUDAMED updates\n\n\n1:45-2:00\nBreak\n\n\n2:00-2:45\nSpeaker: Natalie Pripuzova\,PhD\nTopic: Navigating Regulatory\nExpectations and the\nComplexity of Control Strategy\nin Allogeneic Cell and Gene\nTherapies\nSpeaker: Bryant Foster\nTopic: Finding the Right Dose of\nHuman Factors for Your Medical\nDevice or Combination Product\n\n\n2:45-3:00\nBreak\n\n\n3:00-3:45\nPlenary Session\nTopic: Preparing for Inspections (FDB)\n\n\n3:45-4:00\nBreak\n\n\n4:00-4:45\nSpeaker:Jon Mann\nTopic: Compliance Circling Calibrations\n\n\n4:45-7:00\nDinner\n\n\n\n\n  URL:https://ocra-dg.org/event/fall-symposium-tuesday-october-28th/ CATEGORIES:Events,In Person END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250912T181500 DTEND;TZID=America/Los_Angeles:20250912T203000 DTSTAMP:20260415T204246 CREATED:20250830T211106Z LAST-MODIFIED:20250830T211905Z UID:31924-1757700900-1757709000@ocra-dg.org SUMMARY:September 12th Happy Hour at PRN Medical Solutions DESCRIPTION:OCRA-DG July 11 Happy Hour\nDate: Friday | September 12\, 2025 \nTime: 6:30pm-8:30pm PT\, (Doors open at 6:15pm) \nLocation: PRN Medical Solutions – 17592 E. 17th St. Suite 225\, Tustin\, California \nRegistration: Free! \nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. \n  \nRegister Now \n  \n  URL:https://ocra-dg.org/event/sept-12-2025-happy-hour/ CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250711T174500 DTEND;TZID=America/Los_Angeles:20250711T203000 DTSTAMP:20260415T204246 CREATED:20241105T055333Z LAST-MODIFIED:20250702T052843Z UID:30559-1752255900-1752265800@ocra-dg.org SUMMARY:July 11 Happy Hour DESCRIPTION:OCRA-DG July 11 Happy Hour\nDate: Friday | July 11\, 2025 \nTime: 6:00pm-8:30pm PT\, (Doors open at 5:45pm) \nLocation: PRN Medical Solutions – 17592 E. 17th St. Suite 225\, Tustin\, California \nRegistration: Free! \nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. \n  \nRegister Now \n  \n  URL:https://ocra-dg.org/event/july-11th-happy-hour/ CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250515T180000 DTEND;TZID=America/Los_Angeles:20250515T200000 DTSTAMP:20260415T204246 CREATED:20241105T055103Z LAST-MODIFIED:20250501T011130Z UID:30558-1747332000-1747339200@ocra-dg.org SUMMARY:May 15 Happy Hour DESCRIPTION:OCRA-DG May 15th Happy Hour\nDate & Time: Thursday\, May 15th – 6pm\nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network.\nLocation:\nPostino Park Place\n2981 Michelson Dr.\nSuite E\nIrvine\, CA 92612 \nRegister Now \n  URL:https://ocra-dg.org/event/may-15-happy-hour/ CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250417T160000 DTEND;TZID=America/Los_Angeles:20250417T200000 DTSTAMP:20260415T204246 CREATED:20250304T180608Z LAST-MODIFIED:20250414T041611Z UID:31013-1744905600-1744920000@ocra-dg.org SUMMARY:Leadership Circle DESCRIPTION:Content is protected. URL:https://ocra-dg.org/event/leadership-circle/ LOCATION:Fogo de Chao\, 623 Spectrum Drive\, Irvine\, CA\, 92618\, United States CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250414T180000 DTEND;TZID=America/Los_Angeles:20250417T200000 DTSTAMP:20260415T204246 CREATED:20250225T083721Z LAST-MODIFIED:20250415T000451Z UID:30980-1744653600-1744920000@ocra-dg.org SUMMARY:Ensuring IVD Success: Insights on latest MDCG Guidance\, Technical Documentation\, and Audit Challenges DESCRIPTION:Date: Thursday | April 17\, 2025 \nTime: 6 pm to 8 pm PT \nLocation: Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA 92630 \nRegistration: New Price! Free for OCRA-DG members; $20 for nonmembers \nTopic: Ensuring IVD Success: Insights on the latest MDCG Guidance\, Technical Documentation\, and Audit Challenges \n\nLearning Objectives: \n 1. Understand the EU IVDR requirements \n 2. Identify the differences between IVDD and IVDR \n 3. Identify potential gaps in technical documentation and management systems \n 4. Understand the meaning of the latest MDCG guidances  \n\n\nSpeaker: \nDr. Julien Senac\, Senior Director – Medical and Health Services Americas at TUV SUD \nDr. Julien Senac is currently Senior Director of Medical and Health Services at TÜV SÜD America\, overlooking certification and testing services for medical devices manufacturers. Prior to this\, he has many years of experience with quality and regulatory affairs\, through various notified bodies\, where he participated to the implementation of IVDR\, performed Design Dossier assessment of in vitro diagnostic devices and high risk cardiovascular medical devices. \nDr. Senac has a Ph.D. in Molecular and Human Genetics and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr. Senac has also participated  to the development of multiple biotechstart-up companies in oncology and gene therapy.\n\n\nRefreshments and beverages will be provided! Don’t miss out—two raffle tickets will be up for grabs for the 2025 OCRA Annual Conference! \nRegister now to secure your spot and empower your team for success! \n  \n\n  URL:https://ocra-dg.org/event/webinar-series-ensuring-ivd-success/ LOCATION:Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA\, 92630 CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250314T183000 DTEND;TZID=America/Los_Angeles:20250314T203000 DTSTAMP:20260415T204246 CREATED:20241105T054600Z LAST-MODIFIED:20250224T021701Z UID:30556-1741977000-1741984200@ocra-dg.org SUMMARY:March 14 Happy Hour DESCRIPTION:OCRA-DG March 14 Happy Hour\nDate: Friday | March 14\, 2025 \nTime: 6:30pm-8:30pm PT \nLocation: Postino Irvine at 2981 Michelson Dr suite E\, Irvine\, CA 92612 \nRegistration: Free for OCRA-DG members; $10 for nonmembers \nEvent: Inviting members and nonmembers of the SoCal Regulatory Affairs community to socialize and network. \nShared plates will be provided for attendees. \n  \nRegister Now \n  \n  URL:https://ocra-dg.org/event/march-14-happy-hour/ LOCATION:Postino Irvine\, 2981 Michelson Dr\, Suite E\, Irvine\, 92612\, United States CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250213T080000 DTEND;TZID=America/Los_Angeles:20250213T130000 DTSTAMP:20260415T204246 CREATED:20250107T100848Z LAST-MODIFIED:20250207T011507Z UID:30624-1739433600-1739451600@ocra-dg.org SUMMARY:Spring Seminar DESCRIPTION:  \nThis Event is Sold Out!\nWe have reached the capacity for the 2025 Spring Seminar.\nPlease check our Events Calendar for other great networking opportunities. \n  \n\n  \nAre you ready to expand your knowledge\, connect with industry professionals\, and gain fresh insights to kickstart your spring with purpose? Our upcoming Spring Seminar is the perfect opportunity to do just that! \nWhether you want to learn\, network\, or discover cutting-edge trends\, this event has something for everyone! Don’t miss the chance to be part of OCRA. \nDate: Thursday\, February 13th\, 2025\nTime: 8am – 1pm PT\nLocation: AbbVie Irvine Campus\n2525 Dupont Dr\, Irvine\, CA 92612 \nLet’s learn\, grow\, and make meaningful connections this spring. We can’t wait to see you there! \n  \n\n  \nFDB Speakers \nYear in Review\nJune-Mei Han\nCalifornia FDB \n  \n\n  \nMed Device Industry Speaker \nAI Impact on MDR Conformity Assessment\nBalazs Bozsik\nTechnical Director – Medical Audit/SGS North America \n  \n\n  \nPharma Device Industry Speaker \nPre-IND Communication\nDr. Bruce W. Kovacs\, MD\nAfectaPharm \n  \n\n  \nAbbvie Panel Med Device \nWhich Way FDA\, what should we expect in 2025?\nAlan Stevens \nCombo Product: Director\, Regulatory Affairs\, Combo Product\, AbbVie \nCarlos Torres\nAdvertising and Promotion: Senior Manager\, RA US Advertising and Promotion\, AbbVie \nFelipe Martins\nStrategy: Associate Director\, RA Global Regulatory Strategy\, AbbVie \n  \n\n  \nPharmaceutical Panel Speakers \nPharmaceutical Labeling\nNatalie Tolli\nVP\, RA Intercontinental/ Regulation and Policy Intelligence\, AbbVie \nMirabelle Pao\nDirector\, RA CMC\, AbbVie \nEmily Wawro\nDirector\, RA Global Regulatory Strategy\, AbbVie \n  \n\n\nConference Schedule\nTHURSDAY\, FEBRUARY 13\, 2025\n \n\n\n8:00–9:00: Registration\, Networking & Breakfast \n9:00–9:45: Opening Plenary \n9:45–10:15: Pharma Industry Speaker \n10:15–10:45: Device Notified Body Speaker \n10:45–11:00: Break & Refreshments \n11:00–11:30: Pharma Panel \n11:30–12:00: Device Panel \n12:00–12:30: Closing Remarks & Raffle \n\n\n\n  \n\n  \nWant to Learn More? \nClick on the flyer to learn all the details about the Seminar\, including schedule\, speakers and registration info! \n  URL:https://ocra-dg.org/event/spring-conference/ LOCATION:AbbVie Irvine Campus\, 2525 Dupont Dr\, Irvine\, 92612\, United States CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20250131T180000 DTEND;TZID=America/Los_Angeles:20250131T200000 DTSTAMP:20260415T204246 CREATED:20241105T054128Z LAST-MODIFIED:20250127T204732Z UID:30555-1738346400-1738353600@ocra-dg.org SUMMARY:OCRA-DG Open House DESCRIPTION:Explore upcoming conferences\, webinars\, and networking opportunities while connecting with fellow regulatory professionals over hors d’oeuvres.\n  \n  \n  \n  \n  \n  \nEvent: Introducing the new 2025 Board to OCRA members \nDate: Friday\, January 31\, 2025\nTime: 6pm-8pm\nLocation: Solstice Irvine Seasonal Kitchen & Bar\, 18555 Jamboree Rd\, Irvine\, CA 92612 \nDon’t miss the Raffle at the Open House for:\n3 free tickets to the Spring Seminar\n3 free tickets to the Annual Conference \nThis event is free for Members and Non-Members. \n   \nRegister Now \n  \n\n  \n  URL:https://ocra-dg.org/event/ocra-dg-open-house/ LOCATION:Solstice Irvine Seasonal Kitchen & Bar\, 18555 Jamboree Rd\, Irvine\, CA\, 92612\, United States CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20241114T183000 DTEND;TZID=America/Los_Angeles:20241114T183000 DTSTAMP:20260415T204246 CREATED:20241029T220855Z LAST-MODIFIED:20241105T054833Z UID:30547-1731609000-1731609000@ocra-dg.org SUMMARY:2024 Ocra-DG Holiday Party DESCRIPTION:End-of-year Holiday Party/Member & Sponsor Appreciation Dinner\nDate: Thursday\, November 14\, 2024\nTime: 6:30pm – 9:30m PT\nEvent: A thank you to our members and sponsors. \n  \n\n  \nFree for Members\, Sponsors and Guests \nRegister Now! \n  \n\n  \n  URL:https://ocra-dg.org/event/2024-holiday-party/ LOCATION:Brio Italian Grille Spectrum CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20240917 DTEND;VALUE=DATE:20240920 DTSTAMP:20260415T204246 CREATED:20230807T184635Z LAST-MODIFIED:20240505T052851Z UID:27456-1726531200-1726790399@ocra-dg.org SUMMARY:RAPS Convergence DESCRIPTION: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. \nOCRA Members receive 10% off RAPS Convergence registration rate!  Contact Membership@ocra-dg.org to obtain the special promo code! URL:https://ocra-dg.org/event/raps-convergence/ CATEGORIES:Events,In Person,Joint Meetings,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20240802T080000 DTEND;TZID=America/Los_Angeles:20240802T170000 DTSTAMP:20260415T204246 CREATED:20230228T154326Z LAST-MODIFIED:20240505T053121Z UID:27134-1722585600-1722618000@ocra-dg.org SUMMARY:2024 OCRA 30th Anniversary Annual Conference DESCRIPTION:See https://ocra-dg.org/2024-annual-conference/ for event details! URL:https://ocra-dg.org/2024-annual-conference/ CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20240530T173000 DTEND;TZID=America/Los_Angeles:20240530T193000 DTSTAMP:20260415T204246 CREATED:20240221T193321Z LAST-MODIFIED:20240521T064851Z UID:28019-1717090200-1717097400@ocra-dg.org SUMMARY:IDE Submission Best Practice\, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives DESCRIPTION:IDE Submission Best Practice\, and Pitfalls to Avoid – from Both Regulatory & Clinical Perspectives \nDate: Thursday\, May 30\, 2024 (New Date!)\nTime: 5:30pm – 7:30pm PT\nAudience: Regulatory and clinical affairs professionals in medical device industry\nLocation: Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA 92630 (New Location!) \nThis panel discussion provides an overview of the critical elements for a successful IDE strategy and submission\, focusing on best practices from both regulatory and clinical perspectives. The discussion will focus on case scenarios and pitfalls to avoid\, facilitating the understanding of the content. Attendees will have the opportunity to learn from the discussions and ask questions.\nSubmit your questions after registration and have them answered at the event! \nLearning Objectives: \n\nOverview of IDE submission process\nBest practices of IDE submission and common pitfalls to avoid\nNavigating the review process\nNow you’re approved…what to expect.\n\nAgenda: \n\n17:30   Check in\, light dinner & social networking\n18:00  Introducing OCRA and speakers\n18:10   Panel Presentation and Q&A\n19:10   Open discussion & social networking\, other announcements\n19:30   Adjourn\n\nRegister now to secure your spot and empower your team for success! \n  \n\n\nAbout the Speakers:\n \nMagda Michna\, Ph.D.\, Chief Clinical\, Regulatory and Medical Affairs Officer at STAAR Surgical Company\n \nDr. Michna brings extensive expertise in global clinical\, regulatory\, and medical affairs. Previously\, she held key leadership roles at AcuFocus Inc. (a subsidiary of Bausch & Lomb)\, Presbia LLC\, and within Alcon’s surgical franchise. With a focus on accelerating market entry and driving adoption\, Dr. Michna has spearheaded the development of premium intraocular lens and surgical device technologies. Her strategic leadership and deep understanding of regulatory landscapes have facilitated successful market introductions. \n  \nLaura Schall\, Director\, Clinical Affairs at STAAR Surgical Company\n \nLaura Schall brings extensive experience in clinical research that spans the sponsor and clinical investigator perspectives. Laura started her research career as a Clinical Research Coordinator at a private medical practice\, where she was responsible for the execution of clinical studies. Laura transitioned to the sponsor side\, first as part of a Clinical Research Organization (CRO) before she made the leap into industry\, where she has led the strategy and execution of multiple registration and post-market clinical trials. Laura’s extensive knowledge of clinical research has led to multiple successful product registrations. \n  \n\n  \n\n\nIn-Person Ticket\n$20 for Member\n$35 for Nonmember \nLight fare & beverage provided at 5:30pm PST. \nRegister Now! \n\n\nVirtual Ticket\nFREE for Member\n$20 for Nonmember \nEvent starts at 6pm PST. \nRegister Now! \n\n\nRegister 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/ide-submission-best-practice-and-pitfalls-to-avoid-from-both-regulatory-clinical-perspectives/ LOCATION:Alcon Laboratories\, 20511 Lake Forest Dr\, Lake Forest\, CA\, 92630 CATEGORIES:Events,In Person END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20240226T170000 DTEND;TZID=America/Los_Angeles:20240226T210000 DTSTAMP:20260415T204246 CREATED:20240111T170550Z LAST-MODIFIED:20240130T190244Z UID:27930-1708966800-1708981200@ocra-dg.org SUMMARY:OCRA Open House DESCRIPTION:JOIN US FOR AN OCRA OPEN HOUSE – NEW DATE & LOCATION\nNetwork\, Engage\, and Socialize \nFebruary 26\, 2024 5:00 PM – 9:00 PM \nProgram: \n\nIntroduce the 2024 Board\nVolunteers & strategic partners appreciation\nMembership appreciation\nMembership drive\n\n\nLocation: \nLocation: “Be Good” restaurant in Huntington Beach \nBest Experiences in Huntington Beach\, CA | BeGood Restaurants \nHors D’oeuvres provided. Cash bar. \nParking: Garage next to the restaurant. validation for 2 hours\nCOST: Free to all\, but registration is required. \nRSVP Now! URL:https://ocra-dg.org/event/ocra-open-house/ CATEGORIES:Events,In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20231109T170000 DTEND;TZID=America/Los_Angeles:20231109T200000 DTSTAMP:20260415T204246 CREATED:20230929T125143Z LAST-MODIFIED:20231026T172205Z UID:27764-1699549200-1699560000@ocra-dg.org SUMMARY:Best practices for CLIA lab setup and certification DESCRIPTION:How to be agile in the dynamic regulatory environment without sacrificing quality – Best practices for CLIA lab setup and certification\nThe Clinical Laboratory Improvement Amendments require that clinical laboratories\, including those in healthcare facilities\, reference labs\, public health labs\, and some research labs need to be certified. Many practices for developing Laboratory Tests (LDTs) and establishing a new functioning laboratory are common to CLIA certification and FDA approval. CLIA certification is a first step toward FDA companion diagnostic kit approval. During this session\, you will learn: \n\nHow to set up a CLIA laboratory that meets CLIA standards\nActions to take to be prepared for an inspection\nBest practices for laboratories to implement that will enable them to be ready for regulatory changes\n\nMeeting Details: \nNov. 9\, 2023 \n 5:00 – 8:00 pm \n 2400 Barranca Parkway\, Irvine CA \nRefreshments and soft drinks will be provided \nCOST: Free for OCRA Members & Students\, $15 Non-Members \n\nFeatured Speaker\nLinda Castle\, Senior Consultant \nIntegrated Project Management Company\, Inc \nLinda Castle is a Senior Consultant with Integrated Project Management Company\, Inc. (IPM)\, a national consulting firm focused on providing solutions to complex problems and ensuring strategy realization through disciplined project leadership. She has a long career as a scientist and manager in Life Sciences\, leading discovery\, new technologies\, and product development biotech laboratory teams. She has been a certified project manager focusing on CLIA laboratories for the past seven years\, where she has led LDT development and launch\, tech transfers\, lab construction\, operational efficiency\, and fast-paced laboratory stand-up projects. \nLinda has bachelor’s degrees in math and forest science and a PhD in genetics. She is a certified Project Manager (PMP)\, a SAFe Agile Scrum Master\, and a Six Sigma/LEAN Greenbelt. \n\nQuestions? Contact Fawn Zhang: (206) 639-1311; fawnzhang0@gmail.com \n\nRegister Now! URL:https://ocra-dg.org/event/best-practices-for-clia-lab-setup-and-certification/ CATEGORIES:Events,In Person,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20231010T170000 DTEND;TZID=America/Los_Angeles:20231010T200000 DTSTAMP:20260415T204246 CREATED:20230822T180902Z LAST-MODIFIED:20231003T114621Z UID:27720-1696957200-1696968000@ocra-dg.org SUMMARY:A.I. Is Coming\, Are You Ready? Navigating the Ethical Landscape of Advanced Technologies DESCRIPTION:Speaker: Steven Thompson \nTopic: Advancements vs Ethics – How to safely use advanced technologies and avoid a catastrophe \nSynopsis: 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 ethics. \nToday the security of medical devices is being threatened. AI is or will be solving many security and other issues. During the session\, you will have the opportunity to learn about the recent advancements in AI\, including: \n\nWays the security of medical devices is being threatened\nHow machine learning algorithms can be used for product and process innovation and to identify potential cyber-attacks\nExamples of blockchain technology that is being used to stop systems from being hacked\nHow cloud computing is helping automate routine processes and streamline workloads\nChallenges with AI including violating people’s rights to privacy and eliminating human participation in the R&D and other processes\n\nLocation: 2400 Barranca Pkwy\, Irvine \n5-8pm  \nCost: FREE for members\, $15 nonmember\, parking free\, refreshments & soft drinks are provided \nQuestions? Contact Anand Parikh: anandparikh27@gmail.com \nRegister Now! URL:https://ocra-dg.org/event/advancements-vs-ethics-how-to-safely-use-advanced-technologies/ CATEGORIES:Events,In Person,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20230909 DTEND;VALUE=DATE:20230910 DTSTAMP:20260415T204246 CREATED:20230807T174446Z LAST-MODIFIED:20230905T141233Z UID:27452-1694217600-1694303999@ocra-dg.org SUMMARY:Team OCRA: Relay for Life DESCRIPTION:JOIN TEAM OCRA FOR THE RELAY FOR LIFE\nDate: Saturday\, Sep 9\, 2023\nTime: Team OCRA will meet at 9:30am\, walk starts at 10am\nLocation: Team OCRA will meet in the parking lot at Santa Ana College\, 1530 W. 17th St\, Santa Ana\n\nAs part of this event\, OCRA will be raffling off tickets to five upcoming OCRA events or webinars!\n\n\nIf you can’t make it to the relay but you’d like to donate to this cause\, please see the OCRA donation page for Relay for Life:\nRelay For Life of North Orange County: OCRA | Relay For Life (acsevents.org)\n\n\nReady to join Team OCRA?\n\nRSVP NOW \n\nQuestions? contact fawnzhang0@gmail.com \n  \nA life changing experience! \n \n  \n  URL:https://ocra-dg.org/event/team-ocra-relay-for-life/ CATEGORIES:Events,In Person,OCRA Meetings,Other Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20230810T170000 DTEND;TZID=America/Los_Angeles:20230810T190000 DTSTAMP:20260415T204246 CREATED:20230619T192144Z LAST-MODIFIED:20230728T164032Z UID:27340-1691686800-1691694000@ocra-dg.org SUMMARY:OCRA Volunteer Happy Hour DESCRIPTION:Date: Thursday\, Aug 10\, 2023\nTime: 5-7pm PST\nLocation: Taco Rosa Newport Beach\nCost: free\nParking: free\n\n\nFinger food is provided\, cash bar\nContact: fawnzhang0@gmail.com\n\n\nPlease join us to learn more about the volunteer opportunities at OCRA!\n\n\nJoin the Annual Meeting committee and celebrate OCRA’s 30 year anniversary!\nJoin the Local Host of RAPS Convergence committee\nJoin the educational programs committee\nJoin the social/philanthropic events committee\nJoin the communications (social media & newsletter) committee\nJoin the professional organizations and industry relations committee\n\n\nREGISTER NOW URL:https://ocra-dg.org/event/ocra-volunteer-happy-hour/ CATEGORIES:In Person,Networking,OCRA Meetings END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20230727T170000 DTEND;TZID=America/Los_Angeles:20230727T200000 DTSTAMP:20260415T204246 CREATED:20230619T190144Z LAST-MODIFIED:20230721T152029Z UID:27339-1690477200-1690488000@ocra-dg.org SUMMARY:FDA Inspection Readiness - Common Mistakes and How Companies Can Avoid Them DESCRIPTION:OCRA & PDA Co-Hosted Event \nDate: Thursday\, July 27\, 2023 \nTime: 5-8pm PST \nLocation: Tustin Ranch Golf Club \nSpeaker: Dr. Binh Nguyen\, Former FDA Official \nCost: $25 member\, $50 non-member \nParking: free \n\n\n\n\nREGISTER NOW \n  \n**PLEASE NOTE** This presentation will be dealing primarily with the pharmaceutical industry\, not medical devices. \n  URL:https://ocra-dg.org/event/fda-inspection-readiness-common-mistakes-and-how-companies-can-avoid-them/ CATEGORIES:Events,In Person,Joint Meetings,Networking END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20230525T173000 DTEND;TZID=America/Los_Angeles:20230525T193000 DTSTAMP:20260415T204246 CREATED:20230504T201247Z LAST-MODIFIED:20230515T154445Z UID:27258-1685035800-1685043000@ocra-dg.org SUMMARY:OCRA and Device Alliance Mixer DESCRIPTION:Hosted Event: This event is brought to you by OCRA and Device Alliance\nDate: May 25 from 5:30pm – 7:30pm \nLocation:\n \nTaco Rosa\n2632 San Miguel Dr\, Newport Beach\, CA 92660\nhttps://www.tacorosa.com/ \nCOST: \n\nOCRA or DA members free\nNon-member $25 online or $30 at the door\n\nParking & Entrance: Parking is free and available directly in front of the restaurant \nFood is on the house\, drinks are available via no-host bar. \nREGISTER NOW URL:https://ocra-dg.org/event/ocra-and-device-alliance-mixer/ CATEGORIES:Events,In Person,Joint Meetings,Networking END:VEVENT END:VCALENDAR