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Global ConSeptS - Consultancy is an independent technical consultancy company that was established in November 2008. The company specialises in aseptic processing and Quality by Design projects specific to the global bio-pharmaceutical industry.
Our approach is pragmatic and to-the-point. You are our customer and we want you to get the best technical solution rather than a theoretical proposal.
Although today Global ConSeptS is a one-man company, we want you to be best served. That is why we closely work together with other competent consultancy companies to provide you the best quality for your projects and assure you on-time delivery.
Our customer base is diverse; whether you are a small start-up company or an established bio-pharmaceutical producer, we will support you. If your business is aseptic processing and/or Quality by Design projects of Active Pharmaceutical Ingredients (API's), small or complex molecules or medical devices we are your partner. Whatever your location we will come on-site and assist you.
Contact us at info@global-consepts.com to see how we can work together
Competency
The founder and owner of the company is Mr. Michiel Rook. He has 20+ years of experience in the bio-pharmaceutical industry. He holds a bachelor degree in processing and a master degree in micro-biology.
Past experiences; employed by the Bio-Pharmaceutical division of Millipore Corporation in Europe:
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Performing aseptic process compliance and risk assessment reviews at many customers in Europe, USA, Asia, Africa and the Middle-East
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On-site Validation Master Plan creation and qualification projects at customer' site
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Providing engineering support and advise to new and exisiting aseptic processes
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Regulatory affairs specialist for global cGMP guidance
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Validation consultant both to customers and internal groups
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Managing the European Field Validation group and Customer Laboratory operation
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Managing the European customer training program
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Training customers from operator to scientist level
Prior to Millipore, he spent several years in the Dutch pharmaceutical industry, mainly with qualification projects at Pharmachemie and the Haarlems Allergenen Laboratorium (HAL) both located in Haarlem, The Netherlands.
Michiel is an active member of the ISPE and the PDA. At the latter organisation, he is Co-Chair of the European QbD Workgroup.
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About Us
