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All / Events (50)
September 19Wednesday
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Webinar On "Computer System Validation"
September 19, 2018 from 1pm to 2pm – Online Description : FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device so… Organized by Sam Miller | Type: online, /, webinar
September 25Tuesday
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Webinar On "Process Validation Requirements & Compliance Strategies"
September 25, 2018 from 1pm to 2:30pm – Online Description : This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process val… Organized by Sam Miller | Type: online, /, webinar
September 27Thursday
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Webinar On "ICH Q 10 Change Management System"
September 27, 2018 from 1pm to 2:30pm – Online Description : The requirement for the Quality Unit review and approval of document changes is clear in 21CFR211. However, contemporary regulatory expectations for the control of change goes well bey… Organized by Sam Miller | Type: online, /, webinar
October 4Thursday
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Webinar On "Sequential Sampling to Reduce Inspection Costs"
October 4, 2018 from 1pm to 2pm – Online Description : ANSI/ASQ Z1.4 (formerly MIL-STD 105) is a generally accepted sampling standard for pass/fail data. This webinar will show that, while the standard's double and multiple sampling plans… Organized by Sam Miller | Type: online, /, webinar
October 16Tuesday
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Webinar On "Through the Eyes of an Auditor"
October 16, 2018 from 1pm to 2:30pm – Online Description : Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, IS… Organized by Sam Miller | Type: online, /, webinar
October 18Thursday
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Webinar On "Medical Device Complaints & CAPA"
October 18, 2018 from 1pm to 2pm – Online Description : This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required an… Organized by Sam Miller | Type: online, /, webinar
October 23Tuesday
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Webinar On "GMPs for Active Pharmaceutical Ingredients"
October 23, 2018 from 1pm to 2:30pm – Online Description : In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introducti… Organized by Sam Miller | Type: online, /, webinar
October 24Wednesday
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Webinar On "Building Your Company FDA FSMA Preventive Control Food Safety Plan"
October 24, 2018 from 1pm to 2:30pm – Online Description : All food facilities registered with the United States Food and Drug Administration (FDA) must comply with the requirements under the Food Safety Modernization Act (FSMA) to develop and… Organized by Sam Miller | Type: online, /, webinar
October 30Tuesday
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Webinar On "Medical Waste Management: Compliance & Disposal"
October 30, 2018 from 1pm to 2pm – Online Description : Identification of medical waste and applicable categories, how to properly handle/store different types of waste on-site, lifecycle to include transportation and recycling/disposal.Obj… Organized by Sam Miller | Type: online, /, webinar
November 28Wednesday
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Webinar On "Medical Device cybersecurity following latest FDA Guidance"
November 28, 2018 from 1pm to 2pm – Online Description : The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program must be carefully plann… Organized by Sam Miller | Type: online, /, webinar
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