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All seminar Events (224)
July 10Wednesday
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6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2019
July 10, 2019 from 8am to 2pm – Online Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained… Organized by John Robinson | Type: virtual, seminar
July 11Thursday
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The EU Clinical Trial Regulation - EU Filings & Registrations
July 11, 2019 from 8am to 2pm – Online This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent u… Organized by John Robinson | Type: virtual, seminar
July 12Friday
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6-Hour Virtual Seminar on Clinical Data Management - Part II
July 12, 2019 from 8am to 2pm – Online When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or devi… Organized by John Robinson | Type: virtual, seminar
August 12Monday
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Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA Rules
August 12, 2019 from 8am to 2pm – Online E-mail has long been a staple of people's lives, but as we move into the new digital age, it seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be use… Organized by John Robinson | Type: virtual, seminar
August 16Friday
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Validation and 21 CFR Part 11 Compliance of Computer Systems
August 16, 2019 from 8am to 2pm – Online This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy… Organized by John Robinson | Type: virtual, seminar
October 3Thursday
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A guide to practical Risk Management - Applying ISO14971 and IEC62304
October 3, 2019 at 9am to October 4, 2019 at 6pm – Philadelphia, PA Description: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively… Organized by John Robinson | Type: seminar
November 5Tuesday
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2-day In-person Seminar Applied Statistics for FDA Process Validation
November 5, 2019 at 9am to November 6, 2019 at 6pm – Philadelphia, PA In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through comme… Organized by John Robinson | Type: seminar
December 4Wednesday
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2-day In-person Seminar FDA and U.S. Customs Import Rules and Export Traps in 2020
December 4, 2019 at 9am to December 5, 2019 at 6pm – Washington, DC Background: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government proced… Organized by John Robinson | Type: seminar
February 19Wednesday
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Effective Complaint Handling, Medical Device Reporting and Recalls
February 19, 2020 from 9am to 6pm – Baltimore MD An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necess… Organized by John Robinson | Type: seminar
March 26Thursday
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Applied Statistics for Scientists and Engineers
March 26, 2020 at 9am to April 27, 2020 at 6pm – SFO, CA Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteri… Organized by John Robinson | Type: seminar
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