The ICH Q12 Conference

From 13-14 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

Aug 21

FDA´s Action Plan for Biosimilars ...

The US Food and Drig Administration (FDA) has published its Biosimilars Action Plan in July 2018.

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Aug 21

Data Integrity: Best Practices for using eHRs in Clinical Investigations ...

With the final guidance on the Use of Electronic Health Record Data in Clinical Investigations the US FDA intends to assist sponsors, clinical investigators, contract research organizations (CRO´s), institutional review boards (IRBs), and other interested parties in the use of eHR data in clinical investigations.

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Aug 21

FDA publishes final ICH E17 Guidance on multi-regional trials ...

The US Food and Drug Administration (FDA) published the ICH E17 guideline on General Principles for Planning and Design of Multiregional Clinical Trials.

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Aug 21

Warning letter due to lacking cleaning validation, stability testing and content ...

When various active substances are being manufactured in a shared system, there are specific requirements for cleaning validation. Read here how severely defects regarding cleaning validation, stability testing and content determination can affect an FDA inspection at an API facility.

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Aug 21

Warning letter to Indian drug manufacturer due to various deficiencies ...

Because of the GMP deficiencies found during an inspection in November 2017 and the company's response, which was deemed unsatisfactory by the FDA, the agency has now issued a warning letter. The main complaints: incoming goods testing, release, equipment design and the HVAC system.

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Aug 21

Data integrity still in the focus of FDA: new warning letter to Japanese API man ...

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.

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