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X-WR-CALDESC:Events for OCRA-DG - Regulatory Affairs
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DTSTART;TZID=America/Los_Angeles:20240409T180000
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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
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DTSTART;TZID=America/Los_Angeles:20240415T160000
DTEND;TZID=America/Los_Angeles:20240415T170000
DTSTAMP:20260417T034107
CREATED:20240221T193245Z
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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
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