Upcoming Seminars

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29th & 30th November, 2018
  • Zurich, Switzerland
  • 9:00 AM to 5:00 PM
  • David R. Dills

CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe

Introductions and Overview of the EU Directives Identify the EU Directives and standards applicable to your product Comply with the implementation details and requirements of the EU MDR & IVDR

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29th & 30th November, 2018
  • SFO, CA
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.

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6th & 7th December, 2018
  • Raleigh, NC
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Tougher Import Rules for FDA Imports in 2018

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

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15th & 16th January, 2019
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Richard (Rick) K. Burdick

Applied Statistics for FDA Process Validation

The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled "Process Validation: General Principles and Practices" consists of a three-stage process.

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