The ICH Q12 Conference

From 14-15 November 2018 in Berlin: The ICH Steering Committe published the new ICH Q12 Guideline on "Product Life Cycle Management" only recently. Learn from industry experts, authority speakers and 3 Members of the ICH Q12 Expert Working Group about the new guideline.

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European GMPs and the Role of the QP

Understand the European approach and the legal framework – and get familiar with the unique roles and responsibilities of the EU QP.

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Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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ECA WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

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Latest GMP News

Jun 14

GDP: Are Inspectors looking for Data Integrity? ...

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

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Jun 14

Fertility Drugs stolen in Italy ...

More than 16.000 packages of fertility drugs were stolen in Italy when a truck was hijacked.

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Jun 14

IMPs: Applicability of the GDP-Guidelines ...

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

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Jun 13

MRA with FDA: Two new States accepted ...

Two more EU Member States were evaluated and accepted by the FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.

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Jun 13

Falsified Medicines Directive - securPharm status report for 2018 ...

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018. Read more about the "securPharm Status report 2018".

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Jun 13

FDA opens Docket on Software Products ...

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

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Upcoming Conferences and Courses

Data Integrity Quality Oversight in the QC Laboratory

Berlin, Germany
18-19 June 2018

Data Integrity Quality Oversight in the QC Laboratory
Container/Closure Integrity Testing - Current and coming best practice

Berlin, Germany
19-20 June 2018

Container/Closure Integrity Testing - Current and coming best practice
Data Integrity Quality Oversight in the QC Laboratory AND Post Conference Workshop Audit Trail Review for Laboratory Systems

Berlin, Germany
18-20 June 2018

Data Integrity Quality Oversight in the QC Laboratory AND Post Conference Workshop Audit Trail Review for Laboratory Systems
View more Conferences and Courses

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Audit Trail Review

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Copenhagen, Denmark

28 August 2018

Audit Trail Review

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