Current GMP News and Events. With this newsletter we would like to inform you about the following current GMP trends. Your ECA Team

ECA GMP Newsletter

Dear Sir or Madam,

With this newsletter we would like to inform you about the following current GMP trends.

Your ECA Team


Comprehensive FDA Warning Letter Analysis - Stability Testing on the Rise

Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.


Granulation & Tableting: Process, Scale-Up, Trouble Shooting

 

The root cause analysis often reveals that compression issues such as capping, sticking and weight variations are related to the upstream granulating process. The objective of this intensive training in Vienna (10-12 September 2019) is therefore to provide a deeper insight into functional relationships between granulation and tabletting in order to avoid such problems from the very beginning. The training also covers the critical quality attributes of the different granulation methods, scale-up as well as the GMP-requirements for OSD manufacture in a global comparison. Please see the programme for further information.


Ongoing severe Quality Deficiencies lead to regulatory Action - Part 1

The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.


How to manage global changes efficiently?

 

Change Control systems should be an integral part of the quality management system (QMS) of every company. How to improve your global product life cycle management fulfilling regulatory and GMP requirements will be shown in Heidelberg from 8-9 October 2019. Please see the programme for further information.


Warning Letter due to GMP Deficiencies in Tableting

An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.


100% Control of Parenterals: CCI and Particle Testing

 

This years' meeting of the ECA Visual Inspection Group will take place in Vienna, 8-10 October 2019. Container-/Closure-Integrity Testing and Visual Inspection of Parenterals will be addressed. This year the focus is on understanding how these inspection systems can be implemented and used in compliance with the official requirements. This includes manual and automated inspection systems and all compliance related topics like: training, test sets, validation, trending, AQL-testing and particle evaluation. Please see the programme for further information.


Hard Brexit: MHRA Preparations

The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.


GMP meets GCP in Hamburg

 

Get to know the essential aspects of the organization and the management of IMP supplies, their distribution and the things to consider during the study. This also inlcudes the important interfaces between GMP and GCP as well as the changes in the regulatory landscape of Clinical Trials. Please see the programme for further information on this course from 15-17 October 2019 in Hamburg, Germany.


GMP/GDP Training from your Desk

Online seminars, the so-called GMP/GDP webinars, are a good opportunity to get an update about the latest trends quickly and conveniently. You don't even have to leave your desk. And if you don't have time to attend one of the many live webinars - no problem. You can also order 1:1 recordings of past webinars and play them on your PC on demand. Just take a look at the list of webinar recordings.


Product Transfer - Organisation of a GMP-compliant Site Change

 

This intensive GMP education course from 22-24 October 2019 in Vienna covers the transfer activities and the documentation necessary for a successful site change, including aspects from Quality Assurance, technology and regulatory affairs. All participants will receive electronic copies with examples of transfer documents like plans, reports and a Transfer SOP. Please see the programme for further information.


In case you missed the previous GMP Newsletter, here are the news from last week:

For further recent news please go here.


Forthcoming GMP/FDA Events

Here you will find an updated overview of forthcoming education courses and conferences.

 

Yours sincerely,

The ECA Academy


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