Annex 1 Conference

From 8-9 May 2018 in Berlin: Learn from 14 speakers among others from Hoffmann La Roche, Boehringer Ingelheim, Novartis and 4 GMP Inspectors about the new requirements published in the EU GMP Annex 1 revision.

More about The Annex 1 Conference

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.

Learn more

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.

Learn more

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.

Read more

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.

Find out more

ECA WebAPP – standing out, outstanding

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

Read more

Latest GMP News

Apr 25

New USP Chapter <1210> Statistical Tools for Procedure Validation ...

The final USP General Chapter <1210> has been published. It will become official on May 1, 2018. Read more about  Statistical Tools for Procedure Validation.

More

Apr 25

Be prepared when the GCP inspector asks about Data Integrity ...

Recently a post in the MHRA blog informed about common findings GCP Inspectors have seen across a number of recent inspections. Read more about Data integrity in Clinical Trials.

More

Apr 25

USA: when is a product suspicious, when is it illegitimate? ...

A new FDA guideline is supposed to help the industry in identifying suspicious or illegitimate products. All trade partners are asked to initiate specific actions if such products turn up. Find out more about the FDA instructions in suspicious and illegitimate products.

More

Apr 25

Brexit: EMA appoints new rapporteurs for centralized authorizations ...

In the course of Brexit, the EMA has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. Read more about EMA's procedure for appointing new rapporteurs.

More

Apr 18

Auditing Starting Materials - new APIC Guideline defines Standards ...

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.

More

Apr 18

Again FDA emphasises Importance of written Contracts ...

The US Food & Drug Administration (FDA) has issued a Warning Letter to a US company recommending to have a look at FDA's Guidance on Contract Manufacturing Arrangements.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK