Press Announcements 2020

01.07.2020

Survey about electronic equipment qualification documentation

Wouldn´t a fully electronic documentation sytem work for both parties (supplier and customer) in qualification projects? This we would like to find out - and would thus appreciate it if you took a few minutes to answer some questions.

More Survey about electronic equipment qualification documentation

17.06.2020

GMP/GDP Online Trainings

Face-to-face events are out of the question in the present situation. However, online training options are a very good alternative. Learn more about the different online training options offered by the ECA.

More GMP/GDP Online Trainings

10.06.2020

ECA GMP News Service on Twitter

Get the latest GMP trends quickly and easily anytime and anywhere - with the ECA's service on Twitter.

More ECA GMP News Service on Twitter

03.06.2020

Postponement of Medical Device Regulation: Survey; how do you use the 1 year more?

Due to the Corona pandemic the EU has postponed the coming into force date of the Medical Device Regulation to 26 May 2021. So, there is one more year for the implementation. What do you think about this extra time?

More Postponement of Medical Device Regulation: Survey; how do you use the 1 year more?

26.05.2020

European GDP Association - Advisory Board Change

The European GDP Association has announced a change on the Authority Advisory Board. Johanna Linnolati from the Finnish Medicines Agency FIMEA decided to leave the board. Dr Daniel Müller, who accepted his nomination recently, takes her place.

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13.05.2020

New Version of the ECA Visual Inspection Guidance

The ECA Visual Inspection Group has completed an updated version of the ECA Guide on Visual Inspection of Parenterals.

More New Version of the ECA Visual Inspection Guidance

06.05.2020

Adjusted Cancellation Conditions

In light of the effects COVID-19 has on our work, our social life and our travel behaviour, we have adjusted our cancellation policy to meet with the changes this pandemic has caused.

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22.04.2020

ECA Validation Group launches new Website

The ECA's Validation Group has re-launched its website. With a cleaner design members and those interested can now find valuable information faster and easier.

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08.04.2020

Be Involved in Annex 1 Revision

The ECA and the European QP Association are both named as official stakeholders by EU Commission to comment on Annex 1. A Task Force has been established to prepare the commentation. In order to involve the members of the ECA and the EQPA, a questionnaire was prepared.

More Be Involved in Annex 1 Revision

01.04.2020

ECA Validation Group's Integrated Qualification & Validation Guideline provides new Approach

What is the ECA Validation Group all about? Watch the group's new video and find out. It also provides a summary of their new Good Practice Guide on Integrated Qualification and Validation.

More ECA Validation Group's Integrated Qualification & Validation Guideline provides new Approach

26.03.2020

Important Information for ECA Academy Course Participants regarding the Consequences of the Coronavirus SARS-CoV-2 Pandemic on Events

The call by the German Robert Koch-Institute (RKI) as well as other institutions in the field of disease surveillance and prevention to reduce social contacts in the private, professional and public environment and to recduce travel activities also has consequences for ECA events.

More Important Information for ECA Academy Course Participants regarding the Consequences of the Coronavirus SARS-CoV-2 Pandemic on Events

26.03.2020

New Version of the ECA Container-/Closure-Integrity Position Paper

The ECA Visual Inspection Board Members worked on a new version of the Container-/Closure-Integrity Position Paper, which has now been published.

More New Version of the ECA Container-/Closure-Integrity Position Paper

11.03.2020

European QP Association announces Change in IMP Group Leadership

The European QP Association's (EQPA) IMP Working Group, representing more than 1.500 Qualified Persons (QPs) in the Investigational Medicinal Products (IMP) area and professionals in similar functions from across Europe and beyond, has announced a change in its group leadership.

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11.03.2020

ECA and its Interest Group European QP Association Named as Stakeholders for Final Consultation of EU GMP Annex 1

On 20 February 2020 the European Commission published the final draft of the EU GMP Annex 1. The previous draft had been published after a fundamental revision end of 2017 - and had resulted in more than 6,000 comments. This is why the European Commission will proceed differently with the Final Draft of Annex 1. Read more about the upcoming Stakeholder Consultation

More ECA and its Interest Group European QP Association Named as Stakeholders for Final Consultation of EU GMP Annex 1

18.02.2020

Call for Papers - Quality, Safety and GMP for ATMP

Became a part of ECA Academy's ATMP Conference 2020 and join the speaker team in Heidelberg, Germany.

More Call for Papers - Quality, Safety and GMP for ATMP

15.01.2020

New: English translation Aide memoire Qualification and Validation for Inspectors

GMP legislation and guidelines are occasionally not very specific. The pharmaceutical industry is seeking more concrete interpretations, though, especially coming from regulators. Such an example is the guide "Aide memoire Qualification and Validation - Basic Requirements" for inspectors.

More New: English translation Aide memoire Qualification and Validation for Inspectors

Press Announcements 2020

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