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May 2019

R&Q Webinar: Integrating CERs and Post-Market Surveillance

May 28 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar Integrating CERs and Post-Market Surveillance on May 28 from 1-2pm. CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports. R&Q will explain how the data inputs and…

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June 2019

BIO International Convention 2019

June 3 - June 6
Pennsylvania Convention Center, 1101 Arch Street
Philadelphia, PA 19107 United States
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The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. The key benefits of attending the 2019 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry thought-leaders with over 500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 67 countries.…

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AAMI Exchange 2019

June 7 - June 10
Huntington Cleveland Convention Center, E 6th Street & St. Clair Ave NE
Cleveland, OH 44115 United States
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Join AAMI on June 7-10, 2019 at the Huntington Convention Center of Cleveland for AAMI Exchange. AAMI has changed the name of its premier health technology event from the AAMI Annual Conference & Expo to the AAMI Exchange. The new name and brand promise reflect the Association's commitment to connect the full gamut of AAMI stakeholders—biomedical and clinical engineers, technicians, cybersecurity and sterilization experts, and hospital administrators and managers and the industry's leading service and solution providers. The Exchange will…

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AdvaMed Webinar: China Adverse Event and PMS

June 12 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member AdvaMed on June 12 from 1-2pm EDT for the webinar China Adverse Event and PMS. The session will cover China post market surveillance (PMS).  NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection.  Two key regulations were issued in the past year on AEs and overseas inspection. We will cover key requirements of the regulations, discuss its implications…

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NAMSA Webinar: How to Implement an Effective Internal Audit Program

June 19 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on June 19 from 11am - 12pm EST for the webinar How to Implement an Effective Internal Audit Program. An organization’s internal audit program is more than meeting the requirements of the 21 CFR 820, ISO 13485 or ISO 9001 standards. An effective internal audit program is an essential part of an effective Quality Management System (QMS), and can be a key communication tool in the promotion of continual improvement throughout the organization, as well as provide insight in areas of…

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