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.

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.

Latest GMP News

Aug 16

Notably low number of warning letters issued to device manufacturers in first ha ...

The evaluation of the FDA warning letters regarding medical devices of the first half of fiscal year 2017 yielded a remarkable low number of warning letters. Find out, what the evaluation of the medical devices warning letters in the first half of fiscal year 2018 showed.

More Notably low number of warning letters issued to device manufacturers in first half of fiscal year 2018

Aug 16

What makes a medical device a medical device? New FDA guideline on product class ...

On twelve pages, the new FDA guideline entitled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drug products, medical devices or others.

More What makes a medical device a medical device? New FDA guideline on product classification

Aug 16

New WHO guideline on medical devices and IVDs ...

On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".

More New WHO guideline on medical devices and IVDs

Aug 15

EMA: More GMP/GDP Inspections performed ...

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.

More EMA: More GMP/GDP Inspections performed

Aug 15

FDA´s final Guidance on Elemental Impurities in Drug Products ...

The final FDA guidance provides recommendations regarding the required documentation related to the control of elemental impurities consistent with ICH Q3D and USP General Chapters <232> and <233>. Read more about FDA´s guidance on Elemental Impurities in Drug Products, which applies to manufacturers of noncompendial and compendial drug products.

More FDA´s final Guidance on Elemental Impurities in Drug Products

Aug 15

Brexit: EMA to lose 30% Staff? ...

The European Medicines Agency (EMA) has published a press release and announced the next phase of its business continuity plan. According to this release the Agency will need to further scale back and suspend activities.

More Brexit: EMA to lose 30% Staff?

Upcoming Conferences and Courses

Chicago, Il, USA
August 28-29, 2018

After the MRA: Understand European GMPs and the Role of the Qualified Person (QP)

Copenhagen, Denmark
28 August 2018

Audit Trail Review

Copenhagen, Denmark
28-31 August 2018

Data Integrity - Requirements for a GMP-compliant Data Life Cycle & full-day pre-course session Audit Trail Review

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Statistical Process Control - A key tool for process understanding in the process validation life cycle

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Barcelona. Spain

6-7 March 2019

Statistical Process Control - A key tool for process understanding in the process validation life cycle

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The ICH Q12 Conference

European GMPs and the Role of the QP

Acknowledged GMP/GDP Certification

GMP/GDP Training Matrix

ECA WebAPP – standing out, outstanding

Latest GMP News

Notably low number of warning letters issued to device manufacturers in first ha ...

What makes a medical device a medical device? New FDA guideline on product class ...

New WHO guideline on medical devices and IVDs ...

EMA: More GMP/GDP Inspections performed ...

FDA´s final Guidance on Elemental Impurities in Drug Products ...

Brexit: EMA to lose 30% Staff? ...

Upcoming Conferences and Courses

After the MRA: Understand European GMPs and the Role of the Qualified Person (QP)

Audit Trail Review

Data Integrity - Requirements for a GMP-compliant Data Life Cycle & full-day pre-course session Audit Trail Review

GMP Newsletter

Recommended Event

Statistical Process Control - A key tool for process understanding in the process validation life cycle

Find yourtraining

What do the Guidelines say?

Get the GMP App

GMP Conferences by Topics

Find your
training

What do the
Guidelines say?

Get the
GMP App