Training

29.10.2021

Basic requirements of DSTU EN ISO 22716:2015 in the production of cosmetic products

The program of the event is available only on Ukrainian or Russian

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28.10.2021

Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

The program of the event is available only on Ukrainian or Russian

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14.10.2021

The main provisions of the principles of HACCP. The practice of developing and implementing the principles of HACCP at the enterprise.

The program of the event is available only on Ukrainian or Russian

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06.09.2021

Certification of medical device manufacturing by pharmaceutical companies

PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]

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26.08.2021

Regulatory requirements for medical devices in laboratory practice

PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, […]

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26.08.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

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