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May

MedHF to present at ECA Conference on Design Controls for combination products, Prague 17-18th May 2018

On May 17th – 18th May 2018, medHF will be presenting in Prague, Czech Republic at the ECA’s (European Compliance Academy) course on Human Factors requirements for combination products.

The course is designed for individuals from the pharmaceutical and biotech industry who are involved in the development, industrialization, and control of drug-device combination product. Recent increase to attention in Human Factors have changed the landscape of different strategies adapted to respond to evolving directives, guidances, and standards. This is especially useful for established pharmaceutical companies who may be new to these shifting design approaches.

The course will consist of:

  • Introduction to the discipline of Human Factors Engineering
  • The current state of the regulatory environment for combination products
  • HF requirements for combination products under design controls from IEC62366 and ANSI-HE75
  • HF validation strategy, management, and considerations

For more information and event details, please follow the link below:

https://www.gmp-compliance.org/training/gmp-course-conference/design-control-for-drug-device-combination-products

- medHF, ,

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