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 20

2D Matrix Codes: which countries are already connected to the European Hub? ...

There is not much time left until the safety features have to be implemented. These features are required to comply with the Falsified Medicines Directive, which will enter into force on 9 February, 2019. Meanwhile, a number of national data storage and retrieval systems have joined the EU Hub, as the European Medicines Verification Organisation (EMVO) reported.

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Jun 20

MRA: New Q&As published ...

The European Medicines Agency (EMA) has published an updated set of questions and answers on the impact of the MRA between the EU and the US addressing questions with GMP relevance.

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Jun 20

Product tracing - new FDA requirements ...

The FDA has published a draft guidance which is to standardise the data traceability of products. Find out how long traceability data for products need to be stored according to the new FDA guideline "Standardization of Data and Documentation Practices for Product Tracing".

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Jun 20

Quality defects: EMA updates Defective Product Report Template ...

The European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products. Read more about the updated "Defective product report template".

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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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Upcoming Conferences and Courses

Bioburden Workshop - Regulatory Expectations and Practical Experiences

Berlin, Germany
26-27 June 2018

Bioburden Workshop - Regulatory Expectations and Practical Experiences
Track & Trace Training Course - FMD Mandatory in Eight Months!

Heidelberg, Germany
28-29 June 2018

Track & Trace Training Course - FMD Mandatory in Eight Months!
The Impurities Workshop - Part I: General Strategies

Copenhagen, Denmark
27 June 2018

The Impurities Workshop - Part I: General Strategies
View more Conferences and Courses

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Reduced Sampling / Reduced Testing AND Analytical Instrument Qualification

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Budapest, Hungary

25 February - 1 March 2019

Reduced Sampling / Reduced Testing AND Analytical Instrument Qualification

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