Eutech Validation
eutechvalidation.co.uk

NEWS

 

 

EUTECH LAUNCHES CSV TRAINING

January 2012

 

Eutech Validation has launched two new training courses to help pharmaceutical and healthcare businesses improve in-house validation of computer systems and quality control.

 

The new offering includes a basic course - designed to give managers in the life sciences industry a overview of computer systems validation (CSV) and good automated manufacturing practice (GAMP) - as well as a more advanced training module covering regulations and international CSV requirements. 

 

Both courses, delivered by Eutech Validation's own expert consultants, are designed to help pharmaceutical and healthcare businesses gain greater control over their quality assurance processes. 

 

Per Olsson, managing director of Eutech Validation, explains: "Whether you have a dedicated in-house team or use a consultancy, it is important that managers have a clear understanding about the basic principles and requirements of CSV.  We work closely with our clients to provide their in-house teams with the knowledge they need to implement efficient and effective quality control measures."

 

For more information or to arrange training for your business email Per Olsson at per@eutechvalidation.co.uk

 

Download course profile for Basic CSV and GAMP course

Download course profile for Advanced CSV and GAMP course

"Eutech Validation has launched new training courses to help businesses improve CSV"

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EUTECH TAKES PARTNERSHIP APPROACH

March 2012

 

Eutech Validation has started working alongside some of the industry's leading experts to offer businesses a complete validation solution.

 

Eutech is co-operating with Barbara Morris of Watermark Quality Associates - a UK expert on blood establishment compliance - and automation engineering specialists Knott Automation Projects.  

 

Per Olsson, managing director of Eutech Validation, said: "These new close working relationships are great news for clients - offering access to specialist consultants without the need for additional procurement processes. And this partnership approach also cuts man hours on validation projects -  Eutech can liaise direct with the other consultants to make project management simple and streamlined."

 

 

 



NEW BUSINESS WINS FOR EUTECH VALIDATION

February 2014

 

Eutech Validation has had a strong start to 2014 with a new client win and a number of new business enquiries - all of which have been driven by recommendations from existing clients and contacts.

 

It follows a strong year for the business, which also welcomed a number of new clients during 2013. The majority of new business wins have involved delivering training programmes, but also supporting validation of new applications and improvements to Quality Management Systems (QMS).

 

Per Olsson, managing director of Eutech Validation, said: "It has been very satisfying to gain so many new business wins through positive word of mouth. Validation was never heavily affected by the economic downturn and, as business in general gathers speed this year, we wish all our clients the best. We hope to see many of you for our three day CSV training course, which is being held in Copenhagen for the first time this May." 

 

CSV TRAINING COURSES -  NEW DATES AND LOCATIONS

September 2013

 

Exciting news: we are expanding our training programme, run in partnership with Compliance & Validation Services, to meet growing demand.

 

The 2013 event in Amsterdam was a near sell-out so next year we will cover the same course in two locations for the first time.   Preliminary locations and dates for 2014 are 13th to 15th May in Copenhagen (which is lovely in the spring!) and 18th to 20th November in Amsterdam (which is always lovely!).

 

The three-day computer validation courses will cover all the basics, plus lots of application of CSV to infrastructure, business and control systems. 

 

Delegates on this year's course got training delivered by three industry-leading presenters, comprehensive course binders, and plenty of entertainment (games, video clips, lunches & dinner and boat trip).  They also received a complete Quality Management System for CSV.

 

The event was very well received and, as usual, we will build the 2014 course based on feedback from attendees of previous years. As well as refreshing the presentations (as we always do), we will also be updating the Eutech Validation QMS for CSV for the 2014 course.

 

We hope to see you at one of the 2014 events. For up-to-date information and booking details visit, www.candvs.com.

 

REGISTRATIONS OPEN FOR CSV TRAINING COURSE

March 2013

 

Date: 4th to 6th June 2013 (3 days)

Location: Amsterdam

 

Registrations are now open for our annual GAMP training course.  The course covers all aspects of computer systems validation. It has been put together jointly by Eutech Validation and Compliance and Validation Services.  Last year we made a major refresh and update to the course content and, due to popular demand we will be repeating the course during June 2013.

 

Our own Per Olsson will run the first day and a half, going through all the essential elements of computer systems validation and GAMP including hot industry topics. Trusted guest speakers will then cover specific aspects such as automation systems, infrastructure and business systems.

 

We are aiming to provide you with practical help. So, each delegate will receive a ready-to-use quality management system that includes simple but comprehensive procedures and templates to support computer systems validation. We will also show you examples of completed lifecycle documents. The course is made up of lectures and practical group exercises with plenty of time for questions and answers. We also try to entertain you as well!

 

For more information or to book your place, visit www.candvs.com

 

NEW COURSES LAUNCHED TO MEET DEMAND

October 2012

 

Following the success of June's three-day computer systems validation (CSV) training course in Amsterdam, Eutech ran two basic and two advanced good automated manufacturing practice (GAMP) courses for a private client this month. 

 

If you missed out on the first round of training, there is no need to worry. Plans are already underway for next year's CSV course, which will be held once again in Amsterdam in June and our industry experts are also available to undertake private training courses for clients. For more information on any of our training courses, contact Per Olsson.

 

COMPUTER SYSTEMS VALIDATION TRAINING COURSE OPEN FOR SUBSCRIPTIONS

April 2012

 

A new computer systems validation (CSV) training course, led by Eutech Validation, is now open for subscriptions.

 

The course, which is run in co-operation with Compliance and Validation Services, will take place on 12, 13 and 14 June 2012 at the Radisson Blu Hotel in Amsterdam and focus on practical approaches to CSV. 

 

Eutech has carefully designed the course content to focus on what actually works in real life with respect to the quality management, operation and qualification of computerised data management (business) systems, equipment control systems (packaged and complex) and the associated infrastructure.

 

Speakers will include Eutech Validation managing director Per Olsson along with Eutech associates Steve Morrell and Alison Harrington.  As well as drawing on their own experience, the course leaders will use interactive group activities - such as compiling test scripts - to aid learning. Each delegate will also receive a comprehensive set of example quality management procedures and templates. 

 

Key topics covered by the three-day course include:

 

- Regulatory Rules & Guidance and an overview of Good Automated Manufacturing Practice (GAMP)
- Key terminology explained
- Overview of verification phases for different categories of systems (based on GAMP 5)
- Basing the scope & depth of testing on GxP functionality & product / patient risk
- Routine system operation and managing change
- System, Process and Validation Review
- Effective data management and system retirement
- Infrastructure Verification/Qualification (e.g. Networks)
- Packaged Systems Verification/Qualification
- Verification/Qualification of IS/Business Systems
- Verification/Qualification of Complex Plant Control Systems

 

 For more information and details of how to book your place, please download the course brochure.

NEW CSV COURSE DATES FOR 2017


Eutech Validation is urging Computer Systems Validation professionals to get in early if they want a place on this year's CSV course in Amsterdam.


The course, which this year will run from 7th to 9th November 2017, has been updated to include new modules on data integrity and also covers all the basics of CSV via lots of interactive exercises on the application of CSV for automation systems, business infrastructure and control systems.


Last year's course was oversubscribed so delegates are urged to contact Eutech's partner Compliance and Validation Services as soon as possible to book their place.


Eutech Validation's Per Olsson said: "This course is one of the most popular that we run and this year's course has been updated to ensure it reflects latest developments in the industry including an expanded section on data integrity and how to manage it. Delegates will also get a full set of validation documents for an example system, a complete quality management system including procedures and template forms, a procedure for data governance (as expected by the regulators) and 30-day free email question and answer service following the course."


EUTECH HELPS TIOFARMA BV VALIDATE IN-HOUSE SYSTEMS


Pharmaceutical company Tiofarma BV has successfully validated its in-house systems following just four days training from Eutech Validation.


Tiofarma launched a transition programme in 2014 to move from mainly paper-based administration and operations towards information systems and digital workflows. Jan Altena from Tiofarma said: "The first system went live in Q2 2015 - a bespoke solution to support change control, validated in a tight schedule thanks to training and support from Eutech Validation. Other system solutions are in preparation and will follow soon."


Per Olsson, managing director for Eutech Validation, said: "We ran bespoke training for the in-house team at Tiofarma and project-lead Jan Altena also attended our three-day course in Amsterdam. With no prior knowledge they have successfully validated their in-house systems - an impressive achievement and a great endorsement for our courses."