News

News

News

2021-12-13

Future Topics and Change in the Leadership of the ECA Foundation Validation Interest Group

The famous European association ECA has announced that the leadership team of its Validation Interest Group will be led by Mr. Ralf Gengenbach, Executive Director of gempex GmbH.

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2021-11-12

New ECA Guide on Integrated Qualification and Validation

Ralf Gengenbach, Founder and Managing Director of gempex GmbH and member of ECA, will share New ECA Guide on Integrated Qualification and Validation from Nov. 16 to Nov. 17, 2021.

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2021-10-15

gempex WebSeminar: PMCF – Generating EU MDR Compliant Clinical Data

PMCF studies as a tool for generating clinical data. --- October 2021 --- Register now!

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2021-09-17

Design Pharmaceutical Qualification Processes Efficiently

Ralf Gengenbach, Managing Director of gempex, was interviewed by PQX Pharma Quality Exchange.

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2021-09-08

Cleaning Validation in Pharmaceutical Manufacturing

Online seminar on 09|29|2021: gempex presents as GMP expert the areas "basics of cleaning validation, validation master plan and cleaning validation report" - highlighted by helpful practical examples.

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2021-07-23

New edition of IMDRF codes

The IMDRF revised the IMDRF codes on 2nd March 2021. These can now be used for Adverse Event Reporting.

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2021-06-07

ECA On-line Training | Effective Equipment Qualification according to Annex 15

On June 8, Ralf Gengenbach, founder of gempex China, will be invited to attend an online training organized by ECA to give an in-depth knowledge of efficient equipment qualification.

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2021-04-23

Medical Device Distributors and Importers – watch out!

Revised Regulations for Repackaging and Translations under the EU MDR.

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