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November 2019

Intertek Webinar: Best Practices in Auditing: Statutory and Regulatory Requirements

November 13 @ 2:00 pm - 2:30 pm
Webinar Online Event, OH United States

BioOhio member Intertek's ongoing webinar series, Best Practices in Auditing, takes popular topics from The ISO 9001 Auditing Practices Group and organizes them into six half-hour webinars to give you important information about your management systems certifications and allow you to ask questions. The series continues with the upcoming webinar, Best Practices in Auditing: Statutory and Regulatory Requirements on November 13 at 2 PM. Organisations are required to create a methodology to identify and control the statutory and regulatory requirements that…

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R&Q Webinar: Strategies for Interpreting the IVDR for Successful Implementation

November 19 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar Strategies for Interpreting the IVDR for Successful Implementation on November 19 at 1pm ET. May 26, 2022 is the IVDR date of applicability, which replaces the IVD Directive. The deadline sounds far away, right? Eh… not so, considering the significant changes your organization will need to make in terms of infrastructure, planning, and resources to proceed with successful implementation. Under the IVD directives, most manufacturers were able to self-certify to place their products…

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December 2019

NAMSA Webinar: The Biological Evaluation Plan: How Can a Step Wise-Approach Create Resource Efficiencies?

December 3 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

BioOhio member NAMSA is presented the webinar The Biological Evaluation Plan: How Can a Step Wise-Approach Create Resource Efficiencies? on December 3 at 11am ET. The Table in Annex A (informative) of ISO 10993-1 gives suggestions for the evaluation of biological effects for all medical devices which contact human patients. This is not a prescriptive measure for testing, but rather a guide for evaluating biological safety within the risk management process. While there is commonly more than one way to…

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Intertek Webinar: Best Practices in Auditing: Internal Audit

December 4 @ 2:00 pm - 2:30 pm
Webinar Online Event, OH United States

BioOhio member Intertek's ongoing webinar series, Best Practices in Auditing, takes popular topics from The ISO 9001 Auditing Practices Group and organizes them into six half-hour webinars to give you important information about your management systems certifications and allow you to ask questions. The series continues with the upcoming webinar, Best Practices in Auditing: Internal Audit Value and Best Practices on December 4 at 2 PM. Internal audits ensure that an organisation’s quality management system functions properly. It’s important for…

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