Events

08.05.202410.00-12.00

08.05.2024

Update of Technical Regulations in the Field of Medical Devices. Changes to be Prepared for.

10.05.202411.00-15.00

10.05.2024

Conducting internal audits in accordance with the provisions of DSTU ISO 19011:2019

24.05.202411.00-15.00

24.05.2024

Formation of a technical file for medical devices

07.06.202411.00-15.00

07.06.2024

Quality management system at enterprises importing and selling medical devices. General information.

26.04.202411.00-15.00

26.04.2024

Quality management system at enterprises designing, developing, producing and selling medical products. General information.

12.04.202411.00-15.00

12.04.2024

Communication and interaction with State Service of Ukraine on Medicines and Drugs Control and conformity assessment bodies

29.03.202411.00-15.00

29.03.2024

Organization of contract manufacturing OBL-OEM in terms of technical regulation

01.03.202415.00-17.00

01.03.2024

Post-marketing surveillance. A framework for studying, analyzing and preventing adverse events associated with medical devices on the market.

16.02.202411.00-15.00

16.02.2024

Risk management, the basis of integrated management

02.02.202411.00-15.00

02.02.2024

Legislation of Ukraine in the field of technical regulation of medical devices

22.12.202311.00-15.00

22.12.2023

Quality management system at enterprises importing and selling medical devices. General information.

15.12.202311.00-15.00

15.12.2023

Formation of a technical file for medical devices

30.11.202311.00-15.00

30.11.2023

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

24.11.202311.00-12.00

24.11.2023

The practice of remote audits of manufacturers under martial law

08.11.202309.00-18.00

08.11.2023

Good manufacturing practice: overview of the principles and requirements of the DSTU EN ISO 22716 (GMP) standard

03.11.202315.00-16.00

03.11.2023

Informing about changes to the conformity assessment body

17.10.202311.00-12.00

17.10.2023

Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

12.10.202312.00-12.30

12.10.2023

Requirements, implementation and certification of HACCP / ISO 22000 in the production of dietary supplements

10.10.202318.00-18.30

10.10.2023

ISO 22716 (GMP) requirements for cosmetic manufacturers

04.10.202316.00-18.00

04.10.2023

Introduction of medical devices into circulation for legal sale

22.09.202311.00-12.00

22.09.2023

Recognition of CE certificates in 2023: extension of MDD certificates until the end of 2028, recognition of MDR

21.09.202316.30-17.00

21.09.2023

Standard ISO 22716 “Cosmetics. Good Manufacturing Practice (GMP)”

31.08.202313.50-14.10

31.08.2023

New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer

11.08.202311.00-15.00

11.08.2023

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

13.07.202311.00-14.00

13.07.2023

Informing about changes to the conformity assessment body

20.06.202311.00-15.00

20.06.2023

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

26.05.202311.00-12.00

26.05.2023

The practice of remote audits of manufacturers under martial law

28.04.202310.00-14.00

28.04.2023

Regulatory requirements for the introduction into circulation of medical devices of risk class 1

31.03.202310.00-12.00

31.03.2023

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

03.03.2023

Recognition of EU certificates for medical devices. Actual questions and answers.

03.11.202211.00-15.00

03.11.2022

Relevance of medical device conformity assessment through EC-certificates recognition during martial law

21.10.202211.00-15.00

21.10.2022

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

16.09.202211.00-15.00

16.09.2022

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

21.07.202211.00-15.00

21.07.2022

Technical regulations for cosmetic products. Production certification according to EN ISO 22716:2007.

16.06.202210.00-14.00

16.06.2022

Development and implementation of a quality management system ISO 9001

17.02.202210.00-14.00

17.02.2022

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

16.12.202110.00-14.00

16.12.2021

The most important regulatory changes in the medical device industry. Digest 2021.

02.12.202110.00-14.00

02.12.2021

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

07.10.202115.00-17.00

07.10.2021

Certification of medical device manufacturing by pharmaceutical companies

07.10.202110.30-12.00

07.10.2021

Regulatory requirements for medical devices in laboratory practice

Update of Technical Regulations in the Field of Medical Devices. Changes to be Prepared for.

Conducting internal audits in accordance with the provisions of DSTU ISO 19011:2019

Formation of a technical file for medical devices

Quality management system at enterprises importing and selling medical devices. General information.

Quality management system at enterprises designing, developing, producing and selling medical products. General information.

Communication and interaction with State Service of Ukraine on Medicines and Drugs Control and conformity assessment bodies

Organization of contract manufacturing OBL-OEM in terms of technical regulation

Post-marketing surveillance. A framework for studying, analyzing and preventing adverse events associated with medical devices on the market.

Risk management, the basis of integrated management

Legislation of Ukraine in the field of technical regulation of medical devices

Quality management system at enterprises importing and selling medical devices. General information.

Formation of a technical file for medical devices

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

The practice of remote audits of manufacturers under martial law

Good manufacturing practice: overview of the principles and requirements of the DSTU EN ISO 22716 (GMP) standard

Informing about changes to the conformity assessment body

Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

Requirements, implementation and certification of HACCP / ISO 22000 in the production of dietary supplements

ISO 22716 (GMP) requirements for cosmetic manufacturers

Introduction of medical devices into circulation for legal sale

Recognition of CE certificates in 2023: extension of MDD certificates until the end of 2028, recognition of MDR

Standard ISO 22716 “Cosmetics. Good Manufacturing Practice (GMP)”

New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

Informing about changes to the conformity assessment body

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

The practice of remote audits of manufacturers under martial law

Regulatory requirements for the introduction into circulation of medical devices of risk class 1

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

Recognition of EU certificates for medical devices. Actual questions and answers.

Relevance of medical device conformity assessment through EC-certificates recognition during martial law

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

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

Technical regulations for cosmetic products. Production certification according to EN ISO 22716:2007.

Development and implementation of a quality management system ISO 9001

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

The most important regulatory changes in the medical device industry. Digest 2021.

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

Certification of medical device manufacturing by pharmaceutical companies

Regulatory requirements for medical devices in laboratory practice

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