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GAMP Benelux

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Change of positions in Steering Committee

During the last Steering Committee meeting of the GAMP Benelux COP, formal positions have been re-elected. Due to the promotion of the co-chair Tim Goossens to vice-chair of the European GAMP steering committee, Tim had to lay down his position in the GAMP Benelux COP.

The new formal positions are:

  • Chair: René van Opstal
  • Vice-chair: Tom de Rudder
  • Secretary: Joost Havers

The steering committee congratulates René, Tom and Joost in their new positions and thank Tim and Frans for their effort in their functions for the GAMP Benelux COP. They were a driving force for this COP since our introduction. Tim and Frans will continue their effort in the steering committee as a member.

Next GAMP event: Serialisation

Our next GAMP event will be organised. The topic will be Serialisation.

Serialisation is a hot topic in the Life Science Industry. Manufacturing companies and Packaging companies are struggling to find a solution for this subject. Some suppliers will have a (partly) solution or are working on it. The Life Science sector is designing specifications and does has lot of questions in relation to this subject. With a number of presentation and a lot of time to discuss specifications and possible solutions, the GAMP COP Benelux facilitates you to share your questions and answers.

Event details will follow soon. If you have any ideas, questions or topics for this even, please send them to This email address is being protected from spambots. You need JavaScript enabled to view it. .

A date is to be set.

 

GAMP European Conference: 19-20 September 2012 - Brussels, Belgium

 "GAMP®:   Understanding the Business Benefits and Compliance Risks from Evolving   Computerised Solutions and IT Services"
19-20 September - Brussels, Belgium

Supplier products and outsourced service delivery approaches continue to   evolve. This event will explore effective use of Electronic Laboratory Note   Books, Track and Trace, Product Safety Systems and expanding utilisation of   Cloud Computing services throughout the supply chain.

Product demonstrations, interactive workshops and case studies sharing   real life experiences will enable delegates to understand capabilities and   risks, and develop compliance strategies that support effective   implementation of business solutions.

Hear product and service providers, regulated organisations and global   regulatory authorities provide a balanced perspective of risk and compliance   strategies.

Tracks Include:  

  • Electronic  Laboratory Notebooks    
  • Information Technology    
  • Sustaining and  Improving Compliance in Operation

As I work in the informatics industry with a focus on life sciences,   GAMP represents a perfect forum to understand industry best practices, trends   and future needs in the context of today’s global business challenges facing   our industry. I look forward to this event.

John Helfrich, Senior Director, Accelrys Inc.

ISPE GAMP conferences attract the highest level of validation experts   from a variety of practical backgrounds. This enables you to connect to a   network of specialists, including those who struggle to make sense of the   regulatory expectations in your specific line of business. By segregating the   larger audience into focused tracks, you will be able to discuss, in some   detail, your particular challenges and solutions.”

Heather Longden, Informatics Solution Consultant Team Manager Europe,   Waters Ltd, United Kingdom

Vendor Management event

The ISPE GAMP COP Benelux and Novotek organised a very interesting workshop about Vendor Management in Breda, the Netherlands.

COP members may download the presentations shown at the event from http://www.gamp-benelux.eu/presentations

Participants are kindly requested to fill in the servey for this event at http://www.gamp-benelux.eu/surveys

The ISPE GAMP COP Benelux

 

Congratulations! COP of the Year

GAMP was awarded COP of the year at this year’s AGM held in Dallas last week. 

I would like to thank you all for your considerable contributions over the past year, without which this award would not have been possible.  I think our achievement this year is particularly well deserved given the economic challenges that our organisations face and the constraints that this brings with respect to time and travel.  Please could you pass on these congratulations to your local groups and also the thanks of ISPE, GAMP Council and Steering Committees.

Manufacturing Execution Systems (MES)

The presentations from this event are available at our Presentations session.

 

Please take some time to fill out our survey to improve out future events.

 

Report for Critical Success Factors implementing MES in Pharmaceuticals Manufacturing Facilities
by Peter Sherris <This email address is being protected from spambots. You need JavaScript enabled to view it.>

 

 

 

Update on the Part 11 inspectional assignment

(source: Sion Wyn - GAMP COP Europe steering Committee)

  • So far, the Part 11 inspectional assignments have not yet been started.
    Based on comments of Bob Tollefsen, this has been caused by 'administrative issues/delays'
  • At this moment, CDER has worked around these issues, and has defined the scope of this assignment.
    More specifically, they have created a defined and fixed lists of manufacturing (and clinical) plants subjects to this effort.
    Domestic / foreign distribution within this list is about 50/50%. 
    There are no additional details known of the plants part of this list, nor is it known which selection criteria were used.
  • Timing-wise, the first inspections are expected to start early 2011 with a target assignment completion of Q3-2011.
  • No further dates for next actions after the actual inspection assignment (such as revisions of P11) has been defined.

Lean Validation: The way to go

On Tuesday June 15. the ISPE GAMP COP Benelux organised a Round Table discussion about Lean Validation.

After an introduction from Hans van der Zalm (DSM) a short presentation was given by Frans Boeijen about the ASTM 2500 guideline, followed by the Round Table discussion.

A conclusion from the discussion was that Lean Validation is interesting, but it is just started at this time. many companies still struggle with a traditional Validation process. The ASTM 2500 is a goed starting point to make the validation process Lean.

Other quotes out of the discussion:

  • Risk based approach has already lead to less documentation
  • Lean Validation is a culture change in a company
  • Involve stakeholders upfront
  • Know your customers
  • Ask why we do thinks
  • The purpose of documentation is communication
  • Use a business case to introduce Lean Validation

Participants are requested to follow the servey.

Our next Round Table discussion will be in Brussels on September 20. This discussion is related to the ISPE conference from September 20. to September 23. See our {ln:Events} for details.
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