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March 2019

VWR Webinar: Designing Novel Fluid Sampling Systems for GMP Operations

March 19 @ 9:00 am - 10:00 am
Webinar Online Event, OH United States

Join BioOhio member VWR for the webinar Designing Novel Fluid Sampling Systems for GMP Operations on March 19 at 9am EST. Sampling is a requirement in every process step of biopharmaceutical manufacturing, with an increasing demand on accuracy the closer it comes to final finish. The webinar demonstrates a 4-step process, to develop a highly efficient and accurate sampling system. Get a deep insight into the lifecycle of product development design: Product conceptualization considerations Engineering design and proof of concept Quality…

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NAMSA Webinar: Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary

March 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on Design Control: Understanding the Benefits of Starting Early and Why it's Necessary on March 20 at 11 am. While design control has been a quality system requirement since 1996, many medical device organizations struggle to understand these requirements, as well as when to start the process and how to maximize the benefits of the system. For example, it is often mistaken that a design control process must be complex to meet the regulatory requirements and to ensure delivery of a…

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R&Q Webinar: Biocompatibility: EU MDR and the changing regulatory landscape

March 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on Biocompatibility on March 26 at 1pm EST. This webinar will dive into the increased specificity of the EU MDR from a biocompatibility perspective and how the revised 10993-1 fits into the new requirements. We will share our experiences from the viewpoint of testing laboratory experts and regulatory consultants with biocompatibility experience from both science and regulatory affairs backgrounds. Our goal is to help you understand the changing regulatory landscape in light of…

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April 2019

NAMSA Webinar: Use of OUS Clinical Data in Medical Device Product Development

April 17 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on the Use of OUS Clinical Data in Medical Device Product Development on April 17 at 11 am. In February 2018, the U.S. Food & Drug Administration (FDA) issued a final rule on an updated regulation pertaining to the acceptance of data from clinical investigations conducted outside the United States (OUS) to support IDEs or submissions (i.e., PMAs). While it is common for medical device manufacturers to utilize OUS clinically applicable data (including clinical…

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NAMSA Webinar: How to Select the Right EU Notified Body for IVDR Compliance

April 30 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on How to Select the Right EU Notified Body for IVDR Compliance on April 30 at 10am EST. The objective of this webinar is to provide manufacturers who intend to market in vitro diagnostic (IVD) products in the European Union (EU) and/or Canada with general guidance on identifying, selecting and approving a designated EU Notified Body, in accordance with the regulatory requirements of the various current Medical Device Directives and the recently published European In Vitro Diagnostic Regulation (IVDR 2017/746). Topics to be covered during this webinar include: The role of an EU Notified Body overseeing the IVD Regulation (2017/746); Current challenges Notified Bodies are facing…

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