QA/RA Medical Devices Consultant | Japan
Tag: compliance
EU MDR deadline officially postponed to 2021 due to covid outbreak
The European Council and Parliament officially adopted an amendment to Regulation 2017/745, modifying the most of application dates to May 2021.
2020 Annex 1 draft: new challenges for sterile manufacturers
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended.
GMP Compliance Expert | Osaka (Japan)
PQE Group and Rephine: a partnership for excellence
PQE Group is delighted to announce its new partnership with Rephine, a UK based multinational audit and consultancy company
EU: GDPR is now a reality
Published today in the Official Bulletin of the State, the legislative decree number 101/2018 aligns Italy to the GDPR rules that have been released on May 25th. The decree will be active from September 19, 2018 and aims to bring a step forward for the transparency in the relations between patients and health service; as […]
PQE and SID&GP, together for Data Integrity guidance
PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS – Russian State Institute of Drugs and Good Practices. After the collaboration with COFEPRIS, the Mexican Regulatory Authority, for the creation of the data integrity chapter of the NOM […]