[Dear Sir or Madam,
With this newsletter we would like to inform you about the following current GMP trends.
Your ECA Team
GMP Outlook for 2017 (Part 2)
There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.
GMP Webinar: Audit Trail Review
 | Data Integrity seems to be omnipresent througout the last couple of months. A significant number of deviation findings caused several authorities worldwide to draft and publish guidances: the US FDA in April 2016, the British MHRA in July followed by the PIC/S in August. The more important it is to be on top of what the authorities require. This webinar on Thursday, 16 February 2017, 15.00 – 16.30 h CET will thus provide you with the opportunity to get an update on the critical elements of Data Integrity and Audit Trail Review. To learn more please see the programme. |
How important is "Data Governance" for your Company?
In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.
Modern Validation - Case Studies
 | Join the ECA meeting on Modern Validation - Case Studies at 23-24 February 2017 in Hamburg, Germany, to find out in six case studies how companies implemented the new EU GMP validation requirements. Also, the differences to the FDA Process Validation Guidance will be discussed. Please see the programme for further information. |
Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 2
As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.
Avoiding non-Compliance in Packaging Operations
 | In this training course from 1-2 March 2017 in Copenhagen you will learn how you can avoid compliance issues in the packaging environment. In addition to Quality Assurance topics you will also address technical issues and serilisation of individual packs. Please see the programme for further information. |
USP´s Intent to Revise Chapters on Biocompatibility of Packaging Systems and Medical Devices
The U.S. Pharmacopeial Convention (USP) proposes the revision of general chapters regarding the biocompatibility of materials used in pharmaceutical packaging systems, medical devices and implants. Read more about the suggested modernization of general chapters <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.
How Quality Metrics can foster Continual Quality Improvement
 | Discuss the latest expectations and requirements for Quality Metrics and KPIs and how they are linked to Continual Quality Improvement (CQI) and Business Continuity - in this course from 2-3 March 2017. Please see the programme for further information. |
Hear more than 30 speakers from leading pharmaceutical companies and authorities
The Pharma Congress Production & Technology is unique in Europe. Create your own agenda out of 6 parallel conferences for just 690,- per one day ticket. You can join all conferences offered during the Congress and you can even change from one conference to another after each presentation. In parallel you may visit the PhamaTechnica with close to 90 exhibitors in the field of pharmaceutical production & technology. Hear speakers from 30 leading pharmaceutical companies as well as inspectors. Please find more information on the Pharma Congress Website.
Efficient Batch Record Design and Review
 | Many observations made in inspections are related directly to batch record documents. This fact clearly demonstrates the importance and challenge of implementing a GMP/FDA-compliant batch record design and review. You will learn all relevant aspects of the batch record flow from the master to the review on 30-31 March 2017 in Budapest. Please see the programme for further information. |
In case you missed the previous GMP Newsletter, here are the news from the last GMP Newsletter:
- Is Senior Management really responsible for GMP?
- Interesting Analysis of GMP Inspections published
- Revised USP Chapter <1058> on Analytical Instrument Qualification
- Stimuli article on the proposed USP General Chapter <1220> published in Pharmacopeial Forum
- GMP for ATMP - two Public Rounds of consultation and still a Need for Discussion?
For further recent news please go here.
Forthcoming GMP/FDA Events
Here you will find an updated overview of forthcoming education courses and conferences.
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Yours sincerely,
The ECA Academy
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