BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//OTRADI - ECPv6.18.3//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:OTRADI
X-ORIGINAL-URL:https://www.otradi.org
X-WR-CALDESC:Events for OTRADI
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:20190310T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20191103T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20200308T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20201101T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20210314T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20211107T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200818T080000
DTEND;TZID=America/Los_Angeles:20200818T120000
DTSTAMP:20200716T162427Z
CREATED:20200706T175102Z
LAST-MODIFIED:20200716T162427Z
UID:10000452-1597737600-1597752000@www.otradi.org
SUMMARY:BioPro: Root Cause Analysis and Corrective Action
DESCRIPTION:This 8 hour class will be delivered in two 4-hour modules\, 8/17 and 8/18 \nOverview:\nTwo key goals of a quality management system are to find the root causes of actual and/or potential problems in order to develop and implement permanent solutions that are accepted\, efficient\, and effective. This 1-day workshop will show how to use root cause analysis tools and methods to find the underlying causes of problems that impact an organizations operations and profitability. You will also learn the methodology to address corrective actions. This workshop is perfect for the novice or for those desiring an invigorating refresher. \nOn completion of this training course you should be able to: \nPrioritize root cause analysis and corrective actions based on risk\nIdentify and prioritize problems and create meaningful problem statements\nDifferentiate between remedial actions and root cause analysis\nSelect and use tools to investigate true root causes of problems and to evaluate and prioritize solutions\nUnderstand the components of a good corrective action\nWrite clear\, complete\, and effective corrective action requests\nDevelop successful implementation plans\nEvaluate effectiveness\, suitability and adaptability of implemented solutions/corrective actions \nWho Should Attend:\nThis course is for people tasked with maintaining and improving ISO 9001/AS9100/TS 16949/ISO 13485 Quality Management Systems and for making general improvements in their organizations performance. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/root-cause-analysis-and-corrective-action/2020-08-18/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200817T080000
DTEND;TZID=America/Los_Angeles:20200817T120000
DTSTAMP:20200716T162427Z
CREATED:20200706T175102Z
LAST-MODIFIED:20200716T162427Z
UID:10000451-1597651200-1597665600@www.otradi.org
SUMMARY:BioPro: Root Cause Analysis and Corrective Action
DESCRIPTION:This 8 hour class will be delivered in two 4-hour modules\, 8/17 and 8/18 \nOverview:\nTwo key goals of a quality management system are to find the root causes of actual and/or potential problems in order to develop and implement permanent solutions that are accepted\, efficient\, and effective. This 1-day workshop will show how to use root cause analysis tools and methods to find the underlying causes of problems that impact an organizations operations and profitability. You will also learn the methodology to address corrective actions. This workshop is perfect for the novice or for those desiring an invigorating refresher. \nOn completion of this training course you should be able to: \nPrioritize root cause analysis and corrective actions based on risk\nIdentify and prioritize problems and create meaningful problem statements\nDifferentiate between remedial actions and root cause analysis\nSelect and use tools to investigate true root causes of problems and to evaluate and prioritize solutions\nUnderstand the components of a good corrective action\nWrite clear\, complete\, and effective corrective action requests\nDevelop successful implementation plans\nEvaluate effectiveness\, suitability and adaptability of implemented solutions/corrective actions \nWho Should Attend:\nThis course is for people tasked with maintaining and improving ISO 9001/AS9100/TS 16949/ISO 13485 Quality Management Systems and for making general improvements in their organizations performance. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/root-cause-analysis-and-corrective-action/2020-08-17/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200813T080000
DTEND;TZID=America/Los_Angeles:20200813T120000
DTSTAMP:20200716T162337Z
CREATED:20200706T175246Z
LAST-MODIFIED:20200716T162337Z
UID:10000197-1597305600-1597320000@www.otradi.org
SUMMARY:BioPro: Data Integrity and Good Documentation Practices
DESCRIPTION:Overview:\nData integrity and good documentation practices (GDP) are essential in providing evidence of a safe and effective product. Learn what the key elements of good documentation practices and data integrity are\, how to apply them\, and how to proactively ensure your system is compliant. \nBy the end of the course\, participants will be able to: \nDescribe FDA Regulations for Good Documentation Practices (GDP)\nPerform GDP\nDescribe FDA Guidance for Data Integrity\nApply Data Integrity\nApply Risk Management\, Investigation\, and CAPA to Data Integrity Concerns \nWho Should Attend:\nAnyone who works in a regulated industry \nPrerequisites:\nNo prerequisites required. Overview of FDA Regulations and Quality Systems Overview or relevant experience are highly recommended.
URL:https://www.otradi.org/event/data-integrity-and-good-documentation-practices/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200812T113000
DTEND;TZID=America/Los_Angeles:20200812T130000
DTSTAMP:20200728T163629Z
CREATED:20200728T163629Z
LAST-MODIFIED:20200728T163629Z
UID:10000465-1597231800-1597237200@www.otradi.org
SUMMARY:PDXWIT: The Biology of Belonging
DESCRIPTION:Join PDXWIT with virtual host\, Umpqua Bank and speaker Rajkumari Neogy as we explore the Biology of Belonging! \nWe all have the need to belong. But what is belonging\, really\, and is it possible for different people to experience different levels of belonging? Can belonging be situationally based? And what are the simple ways to create a greater sense of belonging for each of us within our organizations? \nCome learn the four levels of belonging found within organizations and leave with pro tips on how to create a greater sense of belonging among your co-workers and within your culture. \nAgenda:\n11:30 a.m. – Webinar Open\n11:35 a.m.- PDXWIT Introduction and announcements\n11:45 a.m. – Presentation begins\n12:30 p.m. – Q&A\n1:00 p.m. – Event Ends \nOur events are inclusive. ALL people who support our purpose are welcome.
URL:https://www.otradi.org/event/pdxwit-the-biology-of-belonging/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200812T080000
DTEND;TZID=America/Los_Angeles:20200812T120000
DTSTAMP:20200716T162243Z
CREATED:20200706T175429Z
LAST-MODIFIED:20200716T162243Z
UID:10000198-1597219200-1597233600@www.otradi.org
SUMMARY:BioPro: Data Presentation Design
DESCRIPTION:Overview:\nData Presentation Design is a half-day seminar and workshop that will improve your ability to create powerful data-focused presentations. Effective data presentations have tremendous power to influence the opinions and decisions of your audience. Whether you are creating presentations for internal team meetings or for large professional or public audiences\, this course will teach you how to apply effective data visualization design and provides hands-on training with tools that will help you create engaging and persuasive data presentations. \nBy the end of the course\, participants will be able to: \nPrepare engaging introductions for data-focused presentations\nCreate quick and effective data presentation drafts\nUse Excel and PowerPoint to create powerful data visualizations\nDesign data presentations that enhance audience attention and comprehension \nWho Should Attend:\nEngineers\, scientists\, clinicians\, researchers\, administrators\, continuous improvement specialists\, quality assurance personnel\, technical professionals\, management and anyone who presents data. \nPrerequisites:\nParticipants should have a laptop computer that has Microsoft Office for this training class. No prerequisites are necessary for this course.
URL:https://www.otradi.org/event/data-presentation-design/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200811T120000
DTEND;TZID=America/Los_Angeles:20200811T130000
DTSTAMP:20200714T214135Z
CREATED:20200227T170115Z
LAST-MODIFIED:20200714T214135Z
UID:10000166-1597147200-1597150800@www.otradi.org
SUMMARY:Virtual Lunch & Learn: Valuation of Life Science Companies
DESCRIPTION:This Lunch & Learn is a virtual event\, using Zoom Meeting. After registration\, you will receive a link to join the meeting. Grab your own lunch in the comfort of your home or office\, and join us online! \nRegister here \nValuation of Life Science companies can be difficult. It requires a deep understanding of the industry and common valuation methodologies. Furthermore\, based on the size\, stage\, and type of engagement\, different approaches are needed. \nJameson Jenkins and David Hales from Scalar will discuss the importance of understanding the Scope of Work and the different valuation methodologies that can be used to value within this industry.
URL:https://www.otradi.org/event/lunch-learn-valuation-of-life-science-companies/
LOCATION:OR\, United States
CATEGORIES:OBI Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200811T080000
DTEND;TZID=America/Los_Angeles:20200811T123000
DTSTAMP:20200716T161129Z
CREATED:20200706T175651Z
LAST-MODIFIED:20200716T161129Z
UID:10000202-1597132800-1597149000@www.otradi.org
SUMMARY:BioPro: ISO 13485:2016 Internal Auditor Training
DESCRIPTION:This 16-hour class will be delivered in four 4-hour modules Aug 3\, 4\, 10\, 11 from 8:00-12:30 \nOverview:\nTo successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process. \nBy the end of the course\, participants will understand how to: \nDescribe the goals of an internal audit\nState the benefits of internal auditing\nDetermine the requirements of an internal audit\nExplain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.\nPlan an internal audit\, and develop a guide list\nPerform an internal audit\nIdentify nonconformity to requirements during an audit\nReport on an audit and follow up on corrective actions taken in response to audit findings\nDescribe the actions necessary for maintaining a successful audit program \nWho Should Attend:\nPeople tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System. \nPrerequisites:\nThere are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.
URL:https://www.otradi.org/event/iso-134852016-internal-auditor-training/2020-08-11/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200810T080000
DTEND;TZID=America/Los_Angeles:20200810T123000
DTSTAMP:20200716T161129Z
CREATED:20200706T175651Z
LAST-MODIFIED:20200716T161129Z
UID:10000201-1597046400-1597062600@www.otradi.org
SUMMARY:BioPro: ISO 13485:2016 Internal Auditor Training
DESCRIPTION:This 16-hour class will be delivered in four 4-hour modules Aug 3\, 4\, 10\, 11 from 8:00-12:30 \nOverview:\nTo successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process. \nBy the end of the course\, participants will understand how to: \nDescribe the goals of an internal audit\nState the benefits of internal auditing\nDetermine the requirements of an internal audit\nExplain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.\nPlan an internal audit\, and develop a guide list\nPerform an internal audit\nIdentify nonconformity to requirements during an audit\nReport on an audit and follow up on corrective actions taken in response to audit findings\nDescribe the actions necessary for maintaining a successful audit program \nWho Should Attend:\nPeople tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System. \nPrerequisites:\nThere are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.
URL:https://www.otradi.org/event/iso-134852016-internal-auditor-training/2020-08-10/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200806T091500
DTEND;TZID=America/Los_Angeles:20200806T100000
DTSTAMP:20200716T235614Z
CREATED:20200716T233720Z
LAST-MODIFIED:20200716T235614Z
UID:10000459-1596705300-1596708000@www.otradi.org
SUMMARY:Oregon Bio: Introduction to Nikon BioImaging Lab
DESCRIPTION:Come learn about the Nikon BioImaging Lab that supports the biotech industry by providing imaging assay services via simple contracts for startups and large companies alike. These contracts provide access to cutting-edge imaging technology\, skilled experts\, and a wide array of image-based assays and applications. The Nikon BioImaging Lab is a state-of-the-art\, contract imaging facility that provides advanced technologies to support the burgeoning regenerative medicine and biotech sectors. At the lab\, Nikon offers the expertise and equipment required to carry out simple to complex imaging assays that are compatible with a variety of sample types including cells\, tissues and organoids. Customers can choose from a menu of ready-made assays or can work application scientists to develop custom assays. Jeff Byland will provide an introduction to their services and capabilities.
URL:https://www.otradi.org/event/oregon-bio-introduction-to-nikon-bioimaging-lab/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200805T173000
DTEND;TZID=America/Los_Angeles:20200805T200000
DTSTAMP:20200709T214822Z
CREATED:20200709T214822Z
LAST-MODIFIED:20200709T214822Z
UID:10000216-1596648600-1596657600@www.otradi.org
SUMMARY:Founders Live PDX
DESCRIPTION:Our first-ever online event on 6/18 was a huge success. Join us again for the ultimate entrepreneurial experience and virtual pitch competition. Hosted by Josh Barinstein and Nate Miller. \nLooking forward to seeing you all again! \nRegister here! \n(You will receive the YouTube stream URL once you have registered for the event.) \nFounders Live is an unforgettable happy hour competition sweeping the globe where up to five handpicked companies take the hot seat\, with only 99 seconds to pitch their company and describe their value proposition in front of an eager audience. After the pitches and audience Q&A\, the crowd will vote on a winner who will not only receive an award\, but recognition from the crowd and also the opportunity to talk more about their product or service. So bring your friends and coworkers\, grab a drink\, get to know your local entrepreneurs and vote for what you think will be the next big thing… built in Portland. \n#businessevent #businessowner #happyhour #networkevent #startupevent #startupowner #networking #pitch #pitchfest #pitchcompetition #pitching #pitchcompany #entrepreneur
URL:https://www.otradi.org/event/founders-live-pdx-12/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200805T090000
DTEND;TZID=America/Los_Angeles:20200805T110000
DTSTAMP:20200728T170007Z
CREATED:20200728T170007Z
LAST-MODIFIED:20200728T170007Z
UID:10000469-1596618000-1596625200@www.otradi.org
SUMMARY:SCORE Portland: Social Media Basics for Small Business
DESCRIPTION:Make your social media work harder for you! This workshop offers an introduction to the Top 5 social media channels for small businesses\, along with the Top 5 local business listings to generate free marketing exposure for your business. We’ll review simple tips and little-known tricks to optimize your social media for greatest marketing advantage. \nOverview: \nLeverage FREE online marketing opportunities for your small business.\nEstablish a professional and engaging online presence for your brand.\nEnhance SEO and improve online visibility with social media and local business listings.\nWe’ll review the unique strengths and weaknesses of each social media channel\, compare and contrast audience size and demographics\, and review when/why/how each channel is used. \nWe’ll examine the business value of social media and how it can benefit your bottom line. Further discussion points include: Growing your social media audience and creating greater reach & engagement with free online productivity tools (ie: graphic design\, animation\, scheduling\, etc.). \nWith a little online marketing savvy\, even small businesses can make a big impression! \nSocial Media is a huge topic and Stacey will pace this workshop to include the most essential elements within three hours. \nPresenter: Stacey McCormack\, Musimack Marketing \nStacey McCormack is the Founder and CEO of Musimack Marketing\, a digital marketing agency in Tigard\, OR. She specializes in website design\, SEO and social media engagement for small business. \nStacey is passionate about consulting with local business owners to navigate a variety of free online marketing opportunities to increase brand awareness and generate demand for their business. \nA 20-year marketing veteran\, Stacey’s former life in corporate America includes experience across all major media including Radio\, Broadcast TV\, Cable TV\, Newspaper and Digital Advertising formats. Today\, she helps small businesses shine online through website design & development\, SEO\, social media and digital advertising. \nLinkedIn profile: www.linkedin.com/in/staceymccormack
URL:https://www.otradi.org/event/score-portland-social-media-basics-for-small-business/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200804T120000
DTEND;TZID=America/Los_Angeles:20200804T130000
DTSTAMP:20200716T160235Z
CREATED:20200706T182818Z
LAST-MODIFIED:20200716T160235Z
UID:10000214-1596542400-1596546000@www.otradi.org
SUMMARY:PSBA Virtual Lunch & Learn: Conflict to Conversation
DESCRIPTION:PSBA Monthly Lunch & Learn series. \nAbout this Event\nWould you like to actually be heard when you speak? Do you want to grasp differing viewpoints with ease? How about remaining completely comfortable even when taking a stand? It is undisputed that communication is the most important skill we have to succeed in relationship\, in business and in life. Surprisingly\, our training in this vital field has mostly been left to assimilation\, circumstance and sheer determination. \nJoin our Virtual Lunch & Learn with international consultant\, trainer and mediator\, Leezá Steindorf. Leezá will deliver a practical and highly effective training that enables clear\, authentic and powerful communication. This will be an interactive training so please come prepared to ask questions. \nRegistered participants will be sent a Zoom link for this event.
URL:https://www.otradi.org/event/conflict-to-conversation/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200804T080000
DTEND;TZID=America/Los_Angeles:20200804T123000
DTSTAMP:20200716T161129Z
CREATED:20200706T175651Z
LAST-MODIFIED:20200716T161129Z
UID:10000200-1596528000-1596544200@www.otradi.org
SUMMARY:BioPro: ISO 13485:2016 Internal Auditor Training
DESCRIPTION:This 16-hour class will be delivered in four 4-hour modules Aug 3\, 4\, 10\, 11 from 8:00-12:30 \nOverview:\nTo successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process. \nBy the end of the course\, participants will understand how to: \nDescribe the goals of an internal audit\nState the benefits of internal auditing\nDetermine the requirements of an internal audit\nExplain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.\nPlan an internal audit\, and develop a guide list\nPerform an internal audit\nIdentify nonconformity to requirements during an audit\nReport on an audit and follow up on corrective actions taken in response to audit findings\nDescribe the actions necessary for maintaining a successful audit program \nWho Should Attend:\nPeople tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System. \nPrerequisites:\nThere are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.
URL:https://www.otradi.org/event/iso-134852016-internal-auditor-training/2020-08-04/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200803T110000
DTEND;TZID=America/Los_Angeles:20200803T150000
DTSTAMP:20200716T234800Z
CREATED:20200716T234800Z
LAST-MODIFIED:20200716T234800Z
UID:10000461-1596452400-1596466800@www.otradi.org
SUMMARY:TAO Virtual Job Fair
DESCRIPTION:Registration Price\nJob Seekers & Students: FREE!\nTAO Member Tech Company: FREE!\nNon-Member Tech Start Up: $99\nNon-Member Tech Company: $150 \nFOR HIRING TECH COMPANIES\nLike many teams around the world\, we’ve shifted to full-time remote work for the first time. We realize this transition in changing how companies operate\, and also the way they hire. \nWe’re excited to announce the TAO Virtual Job Fair for technology companies who are looking to recruit talent for tech or non-tech roles at their companies on Monday\, August 3rd from 11 am – 3 pm (PST). \nIn the absence of in-person events for the foreseeable future\, we are finding creative ways to support and connect our members with proactive job seekers. So we’ve partnered with PluggedIn\, a technology platform that powers virtual hiring events. \nAt this event\, you will be introduced to an array of talent from students seeking internships to technical and non-technical full-time job seekers. You will be able to quickly evaluate candidates via their one-minute video pitch\, as well as their personal profile and resume. \nWe are hoping this will be a great way to connect your hiring team with a diverse line-up of talent.
URL:https://www.otradi.org/event/tao-virtual-job-fair/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200803T080000
DTEND;TZID=America/Los_Angeles:20200803T123000
DTSTAMP:20200716T161129Z
CREATED:20200706T175651Z
LAST-MODIFIED:20200716T161129Z
UID:10000199-1596441600-1596457800@www.otradi.org
SUMMARY:BioPro: ISO 13485:2016 Internal Auditor Training
DESCRIPTION:This 16-hour class will be delivered in four 4-hour modules Aug 3\, 4\, 10\, 11 from 8:00-12:30 \nOverview:\nTo successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process. \nBy the end of the course\, participants will understand how to: \nDescribe the goals of an internal audit\nState the benefits of internal auditing\nDetermine the requirements of an internal audit\nExplain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.\nPlan an internal audit\, and develop a guide list\nPerform an internal audit\nIdentify nonconformity to requirements during an audit\nReport on an audit and follow up on corrective actions taken in response to audit findings\nDescribe the actions necessary for maintaining a successful audit program \nWho Should Attend:\nPeople tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System. \nPrerequisites:\nThere are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.
URL:https://www.otradi.org/event/iso-134852016-internal-auditor-training/2020-08-03/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200731T100000
DTEND;TZID=America/Los_Angeles:20200731T110000
DTSTAMP:20200728T165351Z
CREATED:20200728T165351Z
LAST-MODIFIED:20200728T165351Z
UID:10000468-1596189600-1596193200@www.otradi.org
SUMMARY:SCORE Portland: Small Business Advocates - The Team in Your Corner
DESCRIPTION:The Office of Small Business Assistance has been helping businesses navigate government regulations since 2014. Trevor Leahy will be talking about some of the common challenges facing businesses both pre-COVID-19 and during phased reopening and recovery. He’ll share the resources provided by the Advocacy team and help answer questions about how businesses can make it in this new frontier.  \nThe Business Advocacy Team provides help to businesses with questions\, concerns\, or problems with state and local government agencies. They thrive on representing the government as approachable and human\, eagerly helping entrepreneurs find answers to their questions and making positive connections. \nTrevor Leahy is the Secretary of State’s Small Business Ombudsman. He has 12 years of state service in Oregon with the Office of Small Business Assistance and the Employment Department. Since 2014\, he has been working with businesses on understanding compliance\, identifying resources\, and navigating the requirements for doing business in Oregon successfully\, even in the face of pandemics. Trevor now manages the office of Small Business Assistance\, where he and the rest of the Business Advocacy Team provide help to businesses with questions\, concerns\, or problems with state and local government agencies. Trevor thrives on representing the government as approachable and human\, eagerly helping entrepreneurs find answers to their questions and making positive connections.
URL:https://www.otradi.org/event/score-portland-small-business-advocates-the-team-in-your-corner/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200730T160000
DTEND;TZID=America/Los_Angeles:20200730T170000
DTSTAMP:20200716T175524Z
CREATED:20200716T175524Z
LAST-MODIFIED:20200716T175524Z
UID:10000458-1596124800-1596128400@www.otradi.org
SUMMARY:Cambia Grove Member-Only Event: Fail Forward - Lessons Learned from Failed Attempts
DESCRIPTION:We welcome our members to come together with innovative\, collaborative discussions around various topics hosted monthly. \nThis is a Cambia Grove Member-Only Event \nWe all know creating something new is hard. A lot of attempts fail. But as innovators\, we must remember to “fail forward”\, learn from our mistakes and get back to our passion of creating a better health care system. So\, grab a drink of your choice and join us for a fun virtual afternoon of you sharing your stories of “failures” and learnings with fellow Cambia Grove Members!  \nMembers share 5-minute stories that can include:  \nWhat was the situation?\nWhat went wrong?\nWhy did it go wrong?\nWhat did you learn from the experience?\nHow did it impact your work moving forward?\nWhat advice would you give to your past self and your fellow innovators?
URL:https://www.otradi.org/event/cambia-grove-member-only-event-fail-forward-lessons-learned-from-failed-attempts/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200730T113000
DTEND;TZID=America/Los_Angeles:20200730T130000
DTSTAMP:20200716T160308Z
CREATED:20200716T160132Z
LAST-MODIFIED:20200716T160308Z
UID:10000457-1596108600-1596114000@www.otradi.org
SUMMARY:Oregon Bio Event: Diversity\, Equity and Inclusion Dialogue
DESCRIPTION:Oregon Bio Invites You to be the Change \nSystem racial and ethnic disparities are not only a societal problem\, but also a health problem. Inequities affect the patients and customers we serve. Do our bio-business priorities advance diversity in attracting and retaining talent\, in populating clinical trials\, in updating supply chain relationships and in delivery of healthcare to underrepresented populations? How can our local biosicence industry move the conversation to improve diversity\, equity and inclusion in our world? Can we each be the change? On July 30\, join your peers for an important equity conversation through the lens of Oregon’s bio and technology community. Hear/respond to a live panel of local experts who will illuminate discussion and the opportunities and challenges for diversifying our region’s bio science industry. We’re inviting you to join us for a dialogue with our local company and industry experts who can share best practices and insightful conversation. Let’s consider how the bio industry can be a force for change.
URL:https://www.otradi.org/event/diversity-equity-and-inclusion-dialogue/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200728T130000
DTEND;TZID=America/Los_Angeles:20200728T140000
DTSTAMP:20200716T160341Z
CREATED:20200716T155847Z
LAST-MODIFIED:20200716T160341Z
UID:10000456-1595941200-1595944800@www.otradi.org
SUMMARY:SciEducate Webinar: Business Plans are a Research Endeavor
DESCRIPTION:Start-ups often look at a “Business Plan” as a necessary evil or a writing exercise.  Indeed\, if you plan to approach a financial institution for a loan\, apply for a small business or SBIR/STTR grant\, pitch your idea to investors\, or enlist the support of a partner\, a business plan is required. However\, I believe that writing a business plan can and should be more than that. The title says it is a research endeavor. In this webinar\, I’d like to convince you of that. A business plan can be an action plan. When you use your business plan as a tool to help you outline action items\, next steps\, and future activities\, you are creating a living\, breathing document. That kind of plan not only outlines where you are and where you want to be but also gives you the directions you need to get there. Lastly\, if the plan is periodically reviewed and updated\, it becomes increasingly valuable over time. It provides valuable historical information to help a business make decisions on the future direction of the company. \nDr. Bilello is a Ph.D. in Molecular Biology and was the former Director of Technology Development at GlaxoSmithKline. In addition to an established track record of innovative basic and clinical research\, Dr. Bilello has experience in both project and organizational management. As an entrepreneur\, Dr. Bilello was a founder of Ridge Diagnostics and a co-founder and Managing Partner of Innovalyst LLC. At Innovalyst\, he worked with companies from small businesses to Fortune 500 companies as well as “Invest NI” Northern Ireland’s regional economic development agency.
URL:https://www.otradi.org/event/business-plans-are-a-research-endeavor/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200728T110000
DTEND;TZID=America/Los_Angeles:20200728T120000
DTSTAMP:20200716T160537Z
CREATED:20200716T155551Z
LAST-MODIFIED:20200716T160537Z
UID:10000455-1595934000-1595937600@www.otradi.org
SUMMARY:TAO & Catalyte Webinar: Process Resiliency - Keeping Everything from Hitting the Fan
DESCRIPTION:Having swiftly adapted their day-to-day operations over the past few months in response to the COVID19 crisis\, many business leaders are now looking beyond the “first wave” of crisis management to developing dynamic processes and creating stable growth environments in order to weather future disruptions. \nJoin Technology Association of Oregon and Catalyte invite you to be a part of a larger conversation on Tuesday\, July 28th starting at 11:00 am focused on process resilience. \nParticipants will learn steps they can take to proactively standardize processes from onboarding and offboarding to institutional knowledge sharing\, to ensure their business — and the people who power it — are prepared to overcome any challenges and uncertainty that may arise in the future. And keep processes from backsliding into old habits.
URL:https://www.otradi.org/event/process-resiliency-keeping-everything-from-hitting-the-fan/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200728T080000
DTEND;TZID=America/Los_Angeles:20200728T120000
DTSTAMP:20200716T161002Z
CREATED:20200706T175924Z
LAST-MODIFIED:20200716T161002Z
UID:10000204-1595923200-1595937600@www.otradi.org
SUMMARY:BioPro: "cGMP" current Good Manufacturing Practices
DESCRIPTION:8 hour class delivered in two 4-hour modules\, 7/27 and 7/28 from 8 a.m. to 12 p.m. \nOverview:\nBuilding upon Overview of FDA and Quality Systems Overview courses\, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical\, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\, to provide them with appropriate strategies for ensuring compliance. \nBy the end of the course\, participants will be able to: \nApply cGMPs to their specific job responsibilities beyond the basic elements.\nEstablish and maintain a quality system that builds quality into the product and allows for implementation of continual improvement.\nUnderstand and interpret cGMPs in a practical manner to be able to apply the “right-sized” Quality Systems and GMPs to fit the specific environment\, taking into account factors such as scope of operations\, complexity of processes\, and appropriate use of finite resources.\nDiscuss specific requirements and strategies for compliance with 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines.\nDefine each of the six-system elements: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\nCourse Outline: \nQuality Systems\nNote: Other courses in the certificate program will provide greater detail in Quality Systems such as CAPA\, Change Control\, Deviation Management\, and Quality Risk Management.\nOrganization and Personnel\nDocumentation (Records and Reports)\nControl of Materials\nProduction Controls\nFacilities and Equipment\nPackaging and Labeling\nLaboratory Controls \nWho Should Attend:\nQuality assurance\, quality control\, regulatory affairs\, validation\, manufacturing\, technical support\, IT\, supply chain\, and engineering professionals in the pharmaceutical\, biopharmaceutical\, or medical device industry.\nAll levels of management who require a refresher course to stay current with GMP regulations and learn from case studies. Service providers and vendors who serve pharmaceutical\, biopharmaceutical or medical device industry clients. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/cgmp-current-good-manufacturing-practices/2020-07-28/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200727T160000
DTEND;TZID=America/Los_Angeles:20200727T170000
DTSTAMP:20200723T153351Z
CREATED:20200723T153351Z
LAST-MODIFIED:20200723T153351Z
UID:10000464-1595865600-1595869200@www.otradi.org
SUMMARY:PIE Event: The Startup Community Way
DESCRIPTION:Join us as PIE mentor Stephen Green talks with Ian Hathaway\, coauthor of The Startup Community Way: Evolving an entrepreneurial ecosystem\, the follow up to Startup Communities: Building an entrepreneurial ecosystem in your city by Brad Feld.  \nIf you have questions about startup communities — or what Portland could be doing to become a better startup community — you won’t want to miss this conversation.  \n“The Startup Community Way is an explanatory guide for startup communities. Rooted in the theory of complex systems\, this book establishes the systemic properties of entrepreneurial ecosystems and explains why their complex nature leads people to make predictable mistakes. As complex systems\, value creation occurs in startup communities primarily through the interaction of the parts—the people\, organizations\, resources\, and conditions involved—not the parts themselves. This continual process of bottom-up interactions unfolds naturally\, producing value in novel and unexpected ways. Through these complex\, emergent processes\, the whole becomes greater and substantially different than what the parts alone could produce. \n“Although we are living in a booming age for startups\, we need to think about the future. When the boom times slow\, what will happen to our startup communities\, and how will we ensure that entrepreneurial success is still within reach for everyone? This book provides a framework for answering these questions\, looking at startup communities as complex systems that—given the right resources and support—can help entrepreneurs succeed and benefit society as a whole. \n“If you have been involved in any way in building a startup community or entrepreneurial ecosystem in your city\, The Startup Community Way is key to helping you understand the next phase of your journey.” \nThe book releases on July 28\, 2020. Preorder your copy.
URL:https://www.otradi.org/event/pie-event-the-startup-community-way/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200727T080000
DTEND;TZID=America/Los_Angeles:20200727T120000
DTSTAMP:20200716T161002Z
CREATED:20200706T175924Z
LAST-MODIFIED:20200716T161002Z
UID:10000203-1595836800-1595851200@www.otradi.org
SUMMARY:BioPro: "cGMP" current Good Manufacturing Practices
DESCRIPTION:8 hour class delivered in two 4-hour modules\, 7/27 and 7/28 from 8 a.m. to 12 p.m. \nOverview:\nBuilding upon Overview of FDA and Quality Systems Overview courses\, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical\, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\, to provide them with appropriate strategies for ensuring compliance. \nBy the end of the course\, participants will be able to: \nApply cGMPs to their specific job responsibilities beyond the basic elements.\nEstablish and maintain a quality system that builds quality into the product and allows for implementation of continual improvement.\nUnderstand and interpret cGMPs in a practical manner to be able to apply the “right-sized” Quality Systems and GMPs to fit the specific environment\, taking into account factors such as scope of operations\, complexity of processes\, and appropriate use of finite resources.\nDiscuss specific requirements and strategies for compliance with 21 CFR Parts 210\, 211\, & 820\, ICHQ7\, and the EU GMP guidelines.\nDefine each of the six-system elements: Quality Systems\, Materials\, Packaging and Labeling\, Production\, Facilities & Equipment\, and Laboratory Controls\nCourse Outline: \nQuality Systems\nNote: Other courses in the certificate program will provide greater detail in Quality Systems such as CAPA\, Change Control\, Deviation Management\, and Quality Risk Management.\nOrganization and Personnel\nDocumentation (Records and Reports)\nControl of Materials\nProduction Controls\nFacilities and Equipment\nPackaging and Labeling\nLaboratory Controls \nWho Should Attend:\nQuality assurance\, quality control\, regulatory affairs\, validation\, manufacturing\, technical support\, IT\, supply chain\, and engineering professionals in the pharmaceutical\, biopharmaceutical\, or medical device industry.\nAll levels of management who require a refresher course to stay current with GMP regulations and learn from case studies. Service providers and vendors who serve pharmaceutical\, biopharmaceutical or medical device industry clients. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/cgmp-current-good-manufacturing-practices/2020-07-27/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200723T130000
DTEND;TZID=America/Los_Angeles:20200723T170000
DTSTAMP:20200716T160844Z
CREATED:20200706T180657Z
LAST-MODIFIED:20200716T160844Z
UID:10000207-1595509200-1595523600@www.otradi.org
SUMMARY:BioPro: Preparing for Regulatory Inspections
DESCRIPTION:Overview:\nMany organizations\, such as FDA\, ISO\, OSHA\, and EPA\, can conduct audits or inspections in a biotech company. Most people view these events as scary\, but there are ways to make them less difficult. The first method is compliance with the applicable rules. After that\, preparation is the key. We will focus on these preparatory techniques\, for example\, using internal auditing as a tool\, developing an inspection procedure\, educating employees\, and conducting mock inspections. Participants will roll-play being auditors and auditees. \nBy the end of the course\, participants will have gained: \nUnderstanding of the role of an auditor\nWays to prepare for an audit or inspection\nMethod for conducting a mock inspection\nTips on communicating with inspectors and auditors\nCourse Outline: \nIntroduction to FDA inspections\nIntroduction to ISO audits\nOverview of other regulatory inspections\nCompare and contrast\nPreparation tools and techniques\nCommunicating with inspectors/auditors\nResources \nWho Should Attend:\nAnyone working in a medical device or drug company! Specifically\, managers\, supervisors\, and personnel in customer service\, purchasing\, engineering\, manufacturing\, quality assurance\, or related disciplines. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/preparing-for-regulatory-inspections/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200723T120000
DTEND;TZID=America/Los_Angeles:20200723T130000
DTSTAMP:20200716T160758Z
CREATED:20200706T182653Z
LAST-MODIFIED:20200716T160758Z
UID:10000212-1595505600-1595509200@www.otradi.org
SUMMARY:PSBA Virtual Lunch & Learn: Allyship & Confronting Prejudices in the Workplace
DESCRIPTION:PSBA Monthly Lunch & Learn series. \nAbout this Event\nIn this session\, Dr. Martinez will share some best practices related to being a good ally and confronting prejudice in workplace (and other) contexts. He will also devote quite a bit of time to addressing participants’ questions about stereotypes\, racism\, sexism\, language\, and any other topics related to diversity and inclusion. \nJoin our Virtual Lunch & Learn with Dr. Larry Martinez\, Assistant Professor in the Department of Psychology at PSU. Dr. Martinez’s work is focused on inclusion\, diversity\, stereotyping\, prejudice\, and discrimination in the workplace and has been published in the Journal of Applied Psychology\, Journal of Management\, Journal of Business and Psychology\, Journal of Vocational Behavior\, and several other journals. He serves on the editorial boards of the Journal of Business and Psychology\, Psychology of Sexual Orientation and Gender Diversity\, and Journal of Homosexuality. \nRegistered participants will be sent a Zoom link for this event.
URL:https://www.otradi.org/event/allyship-confronting-prejudices-in-the-workplace/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200723T110000
DTEND;TZID=America/Los_Angeles:20200723T120000
DTSTAMP:20200716T155319Z
CREATED:20200716T155319Z
LAST-MODIFIED:20200716T155319Z
UID:10000454-1595502000-1595505600@www.otradi.org
SUMMARY:TAO Virtual Lunch & Learn: Marketing in Times of Crisis
DESCRIPTION:Marketing can be extremely tricky even during the best of times\, but during a crisis it calls for a more well-thought-out approach that will need to be closely monitored and constantly adjusted to respond to a changing landscape of events. \nThe crisis surrounding COVID-19 has created tremendous upheaval in the world of marketing where budgets are being cut and reallocated\, headcount is being reduced\, and outsourcing is on the rise – even as fundamental building blocks are expected to remain intact. \nJoin Technology Association of Oregon and Muddy Gecko for a conversation on Thursday\, July 23rd starting at 11:00 am where we will reaffirm the foundations of marketing and take a journey through the actions that many of the leading companies in the United States are taking to adjust to this “new normal”.
URL:https://www.otradi.org/event/tao-virtual-lunch-learn-marketing-in-times-of-crisis/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200722T130000
DTEND;TZID=America/Los_Angeles:20200722T170000
DTSTAMP:20200716T160718Z
CREATED:20200706T180847Z
LAST-MODIFIED:20200716T160718Z
UID:10000208-1595422800-1595437200@www.otradi.org
SUMMARY:BioPro: Quality Systems Overview
DESCRIPTION:Overview:\nQuality Systems (QS) are sometimes viewed as a necessary evil or belonging only to production and QA personnel. However\, effective QS can help a business not only comply\, but excel. This course focuses on medical device companies and how to create\, implement\, and improve QS that match your company. Both FDA QS and ISO QS will be discussed. We will also cover: how different departments are impacted by QS\, the biggest pitfalls in establishing and maintaining QS\, and how to critically evaluate your QS. There will be group exercises and lots of interaction among participants to provide multiple options. In QS\, it is definitely true that one size does not fit all! \nBy the end of the course\, participants will have gained: \nFamiliarity with QS concepts\nTechniques for organizing and managing QS\nBest practices for working in QS\nMethods for adapting your QS to be most effective\nCourse Outline: \nIntroduction to FDA and ISO\nLifecycles of QS\nMyths about QS\nOrganizing principles\nManaging principles\nQuestions to consider\nResources \nWho Should Attend:\nThis course is aimed at medical device personnel with some familiarity with QS. It will be beneficial to those with limited knowledge of QS\, but we will NOT be going step by step through all the requirements of a quality system. Recommended for those in customer service\, purchasing\, manufacturing\, engineering\, quality assurance\, or related disciplines. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/quality-systems-overview/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200722T120000
DTEND;TZID=America/Los_Angeles:20200722T130000
DTSTAMP:20200624T195131Z
CREATED:20200219T221044Z
LAST-MODIFIED:20200624T195131Z
UID:10000161-1595419200-1595422800@www.otradi.org
SUMMARY:Virtual Lunch & Learn: They Said it Couldn't be Done! De-Risk Your Projects
DESCRIPTION:“They said it couldn’t be done! Let’s talk about de-risking your projects.” Register here. \nAbout this Event: \nThis Lunch & Learn is a virtual event\, using Zoom Meeting. After registration\, you will receive a link to join the meeting. Grab your own lunch in the comfort of your home or office\, and join us online! \nThere are far more ways to fail than to succeed when developing new products. This presentation will provide three case studies illustrating how to increase the chances of getting medical devices to market. The talk will touch on four primary risk factors: \n\nTechnical risks\nExecution risks\nFinancial risks\nMarket risks\n\nWe’ll also discuss ways to increase the chance of success. The presentation will conclude with “Pearls of Wisdom… and Lessons Learned.” \nAbout the speaker: \nMarc Fine is a serial entrepreneur and Director of Market Development at Andrews-Cooper. He has more than 30 years’ experience taking new products to market\, having had key roles in several major breakthrough medical products\, including: Diasonics (first digital ultrasound imaging system)\, Teknar (first bi-plane prostate imaging system)\, and SRI International (da Vinci Robotic Surgery System). He has a graduate degree in Public Health from UC Berkeley. Connect with Marc on LinkedIn. \nThank you to Andrews-Cooper for sponsoring this event!\n 
URL:https://www.otradi.org/event/lunch-learn-andrews-cooper/
LOCATION:OR\, United States
CATEGORIES:OBI Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200721T130000
DTEND;TZID=America/Los_Angeles:20200721T170000
DTSTAMP:20200716T160642Z
CREATED:20200706T181015Z
LAST-MODIFIED:20200716T160642Z
UID:10000210-1595336400-1595350800@www.otradi.org
SUMMARY:BioPro: Overview of FDA Requirements
DESCRIPTION:Overview:\nThe FDA has more power to affect regulated companies than almost any other organization\, yet many people don’t understand it. Many others ignore it as much as possible. But the FDA affects the job of every person in a medical device or drug company. This course is designed to provide participants with insight into what the regulations are\, why they are there\, where they fit together\, when they apply\, and how to interpret them. We will not just discuss Quality Systems and Good Manufacturing Practices\, but also submissions\, registration\, clinical trials\, recalls\, and adverse event reporting. Each participant will develop a better understanding of the environment in which their company exists and how they can help their company thrive. \nBy the end of the course\, participants will have gained: \nFamiliarity with FDA concepts and organization\nAn understanding of how their jobs are impacted by FDA regulation and how they can lessen the regulatory burden on their company\nAwareness of the most important regulations\nWays to think about regulation constructively and creatively\nInformation resources for further knowledge acquisition\nCourse Outline: \nFDA Organization and philosophy\nOverview of the types of regulations\nMedical device regulation throughout the product lifecycle\nDrug regulation throughout the product lifecycle\nHow to approach regulations\nNavigation of the FDA website \nWho Should Attend:\nAnyone working in a medical device or drug company! Specifically\, managers\, supervisors\, and personnel in manufacturing\, engineering\, quality assurance\, or related disciplines. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/overview-of-fda-requirements/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20200721T120000
DTEND;TZID=America/Los_Angeles:20200721T130000
DTSTAMP:20200717T194648Z
CREATED:20200717T194534Z
LAST-MODIFIED:20200717T194648Z
UID:10000462-1595332800-1595336400@www.otradi.org
SUMMARY:Pregame Your Business: Free Preview Workout
DESCRIPTION:What do you want to achieve most in your business — and where are you stuck? \nJoin Pregame for a full fitness assessment of your business so you can spring clean your strategy and move forward faster. Plus\, get a preview of our Summer Series with Oregon Entrepreneurs’ Network! \nYou’ll walk away with: \nClarity on your most immediate priorities\nA commitment to specific actions that will move you forward\nReasons why goals fail and what to do about it\nPro tips for making things easier and more streamlined today\nHow to stay accountable for what you know you should do!\n[great for] entrepreneurs\, founders\, creators \, small business owners\, self-employed pros \nFree with RSVP!
URL:https://www.otradi.org/event/pregame-your-business-free-preview-workout/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
END:VEVENT
END:VCALENDAR