BEGIN:VCALENDAR VERSION:2.0 PRODID:-//BioCT - ECPv6.3.3.1//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:BioCT X-ORIGINAL-URL:https://bioct.org X-WR-CALDESC:Events for BioCT REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20190310T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20191103T060000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20191010T150000 DTEND;TZID=America/New_York:20191010T180000 DTSTAMP:20240328T051244 CREATED:20191004T193320Z LAST-MODIFIED:20191004T193320Z UID:2996-1570719600-1570730400@bioct.org SUMMARY:BIOMEDICAL CAREER FAIR 2019 DESCRIPTION:The career fair will consist of a 3-hour corporate networking session where attendees can visit company booths to learn more about specific companies and career paths\, as well as provide companies the opportunity to recruit highly qualified JAX-GM and UConn Health Ph.D. candidates and postdocs. The final hour will include a more informal reception where company representatives can further interact with trainees over light refreshments. URL:https://bioct.org/event/biomedical-career-fair-2019/ LOCATION:The Jackson Laboratory\, 10 Discovery Drive\, Farmington\, CT\, 06032 END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20191010T170000 DTEND;TZID=America/New_York:20191010T190000 DTSTAMP:20240328T051244 CREATED:20190924T145610Z LAST-MODIFIED:20190924T145610Z UID:2960-1570726800-1570734000@bioct.org SUMMARY:Understanding GxP Regulations for Healthcare - Presented by MIT Enterprise Forum Connecticut DESCRIPTION:Understanding GxP regulations and implementing a quality system is often minimized by smaller companies in favor of activities that are perceived as added values\, such as patents\, licenses\, and technological partnerships. But neglecting such a system until the development is completed and the product is launched can be risky. Having a quality system in place sooner rather than later could be a game-changer when it comes time to look for potential partners. \nIn this program\, we will: \n\nLearn the GxP compliance requirements and expectations of major healthcare regulators\nDiscuss how smaller companies that may not have deep expertise in QA and GMP/GCP compliance can build a quality system\nDiscuss best practices for managing a regulatory inspection\n\nPanelists: \n\nJohn Hanly\, QA Validation Manager\, Pfizer \nJohn has spent over 30 years at Pfizer in various areas of manufacturing bulk active pharmaceutical ingredients and Quality Assurance organization for clinical manufacturing activities in Groton\, CT. In his current role at Pfizer John is primarily involved with qualifying solid dose manufacturing equipment and validating related computer systems. This also entails quality investigations\, change management and regulatory compliance. In 2016\, John was part of a team that built Pfizer’s first continuous tablet manufacturing facility which won an ISPE (International Society of Pharmaceutical Engineers) Facility of the Year Award. In 2018\, John helped launch Pfizer’s first commercial product (Daurismo) using the new continuous manufacturing technology. John holds a BS in chemical engineering from Worcester Polytechnic Institute\, an MBA in Operations Management from Rensselaer Polytechnic Institute\, and is a Registered Professional Engineer in the State of Connecticut. \n\nDavid King\, Manager – R&D Innovation Team\, Bayer \nDavid leads a small team of technologists exploring innovative technologies to support Life Sciences R&D at Bayer. Over the last 20 years at Bayer\, David has focused on leading organizational change\, digital transformation\, innovation methodologies\, project management and GxP validation. Most recently\, David was the IT lead for the Wearable POC for Bayer’s Digital Device platform\, which provided a platform and business processes to enable digital monitoring and interactions with patients using biosensors\, wearables\, and mobile applications. David earned an MBA from Northeastern University and has worked in IT as a Developer\, Project Manager and Manager across industries including Financial Services\, IT Consulting and Life Sciences R&D. \nAgenda: \n[5:00 – 5:30 PM]\nRegistration and networking\n[5:30 – 7:00 PM]\nProgram URL:https://bioct.org/event/understanding-gxp-regulations-for-healthcare-presented-by-mit-enterprise-forum-connecticut/ LOCATION:Digital Surgeons\, 470 James Street\, Suite 001\, New Haven\, CT\, 06513\, United States END:VEVENT END:VCALENDAR