Press Announcements 2011

Rapid Microbiological Methods Database updated with new Systems

The RMM Working Group's database with Rapid Microbiological Methods Systems is continuously growing. Please see the information on just added and updated systems.

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Concept Heidelberg takes over GMP eLearning Area from MediaVision

Effective from 1 October 2011 Concept Heidelberg has taken over the eLearning programmes from MediaVision in Netherlands. This new service will also be available to the ECA community as the information and training services provider has been entrusted by ECA. Read more here.

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New Endotoxin Testing System based on ELISA

A new rapid microbiology method is being marketed for endotoxin testing. The EndoLISA has been developed by a company called Hyglos and was launched on 1st September 2011. Read on.

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Rapid Micro Methods Database updated with new Systems

With the addition of new systems from BioVigilant and  from Pall Life Sciences the database now comprises 29 different systems. Read more.

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Participate in a Survey on the new EU Approach to Process Validation

Two weeks ago we invited you to let us know what you think about EMA's new approach to Process Validation. While the present guidelines mainly emphasise the validation batches and the verification of a validation process, the main focus of the announced revision of EMA´s Note for Guidance on Process Validation is on the product life cycle. So, if you haven't had a chance to complete our brief survey, we still appreciate your opinion.

European Compliance Academy (ECA) becomes Lufthansa Mobility Partner

After Lufthansa already offered special discounts for attendees of selected ECA courses and conferences, ECA now becomes Lufthansa mobility partner. Find out here what that means for you.

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Sanofi-Aventis Ukraine supports ECA Workshop on Registration of Medicines in Ukraine

For the representatives of the State Expert Center of the Ministry of Health of Ukraine, in charge of registration of medicinal products in Ukraine, the European Compliance Academy (ECA) conducted a workshop on “Regulatory Requirements for the Registration of Medicinal Products and Post-Registration Liabilities in the Countries of the European Union. Regulations on Biosimilars.” This workshop was supported by Sanofi-Aventis Ukraine. Read more.

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Participate in a Survey on the new EU Approach to Process Validation

The present guidelines on process validation mainly emphasise the validation batches and the verification of a validation process. In contrast to that the main focus of the announced revision of EMA´s Note for Guidance on Process Validation is on the product life cycle. But what do you think about EMA´s new approach? Tell us in our brief survey.

What are the Expectations for in-house or Third Party Audits of API Manufacturers?

Manufacturers of medicinal products are required by EU Directive 2001/83 to regularly audit all their API manufactures to make sure that all APIs are manufactured according to EU GMP Part II (ICH Q7). But what are the expectations with regard to audits at API manufactures? To get more information and a short checklist please see the QP Association's news

Free of charge Quality Management Manual and ISO 9001 versus ICH Q10 Matrix

Participants of the ICH Q10 Training Course in Budapest will not only receive a Quality Management Manual of a fictive company but also a matrix comparing the ICH Q10 Guideline with the international quality management standard ISO 9001 at no costs. Learn more about the practice oriented training course in the programme. In addition you will be able to benefit from a training course on ICH Q9 being offered at the same time and get a discount if you register for both courses. Read more here.

Sandra Gay and Geert Verdonk become members of the advisory board of ECA's Rapid Methods Group

Effective since 1 September Geert Verdonk from MSD in Oss/Netherlands and Sandra Gay from bioMérieux in Lyon/France become members of the advisory board of ECA's Rapid Microbiological Methods Working Group. Learn more about the new board members.

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Help us learn about you

Knowing more about you and your experience and concerns would help us to get a better understanding of your interests, systems in use etc. And it would really help us to develop further activities, pre- or post-conference workshops or even new sub-groups. For that reason we would appreciate it very much if you helped us to learn - by completing our brief questionnaire (if you haven't done so already).

GMP Guidelines - GMP Reports - GMP Matrix

Do you have the most important GMP Guidelines on your desk? If yes, is this the current version? You can purchase the most important GMP Guidelines from FDA and EU as well the FDA cGMP, EC GMP and ISO 9000 Matrix online in our webshop. You may also consider the FDA Warning Letter Report - a detailed analysis of the GMP findings of FDA. An important tool to improve compliance with FDA legislation. You will find our bookshop here.

Facelift for European QP Association Website

To give the huge amount of information a better structure and to arrange its website more clearly, the European QP Association decided to give its internet platform a new look and feel. Read more.

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PAT and QbD in the light of FDA´s new Guidance on Process Validation

The University of Heidelberg and ECA jointly organised six successful PAT and QbD/PAT Conferences in recent years. This year’s conference will specifically review QbD/PAT in the context of FDA’s recently issued Guidance for Industry on Process Validation. Please find more information at www.pat-conference.org

How to find GMP Suppliers in the Field of Engineering and Manufacturing Equipment

ECA has been supporting the Pharma Congress for 3 years now. Today, the Congres is the major Get-Together in the field of GMP/FDA compliant engineering and technology services in Europe, attracting more than 1000 delegates and visitors. The exhibition with nowadays 80 leading suppliers has always been booked up, and for 2012 more than 60% of the booths are booked already again. Among the 2012 exhibitors you will find leading suppliers such as Bosch, Groninger, Chemgineering, Uhlmann, Pall, nne Pharmaplan, Sartorius, Bayer Technology Service. Please see the Congress website to find a complete list.

New Developments in Alternative Pyrogen Testing

Two additional presentations about the current developments and experiences on Alternative Pyrogen Testing. More details can be found here.

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GMP for Medical Devices

The manufacturers of Medical Devices have to comply with specific GMP requirements in Europe and in the US. A number of different regulations have been developed by the regulators. Combination products (products that combine drugs, devices, and/or biological products) are also getting the attention of the regulators. Therefore ECA offers an inhouse training course dedicated to GMP for Medical Devices. You can find a list of all GMP inhouse training courses here.

Lufthansa Offer: Special Air Fares for Conference Attendees

Lufthansa agreed on a partnership for selected events. As the Official Airline to these events, Lufthansa offers special prices and conditions to all attendees at following events (please read the information on the webpages to learn more about this special offer):

The 14th European API Conference will be held in Munich

The APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe’s leading event with more than 200 delegates from 30 different countries. Speakers from FDA, EMA, EDQM, National EU Authorities and from Industry already confirmed their presentations. APIC and ECA Members will receive a discount on the regular conference fee. Please visit www.api-conference.org for further information.

GMP Conferences by Topics

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