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September 18, 2013

PAT/QbD - Keeping an Eye on Your Quality

Speakers for this Event:
  • Jan Verelst, M.Sc. Chemical Engineering, International Business Development Manager for Life Sciences, Siemens   Learn More
  • Kjell Francois, Ph.D., Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT   Learn More
  • PAT is a reality for the pharmaceutical and life science industries. In-process data and data analysis tools significantly improve process understanding and control, ensuring quality and reducing the risk of non-compliant products.

    • For an existing production, the benefits can be seen in terms of reduced cost, lower inventory levels and a move towards just-in time production and supply
    • For a new production, the benefit is the ability to quickly develop the manufacturing process, upscale to a robust process and perform validation more easily

    There are a number of tools that support PAT principles in development and manufacturing plants, such as process analyzers, process control tools and reporting tools. But to properly implement PAT, you need more than just supporting tools. You need software that intelligently interprets and interconnects data generated by these quality tools. Software that installs absolute data transparency by returning correlated data back to processes from product development onward and software that can make valuable predictions to continuously improve quality and efficiency. Siemens has developed a software solution, SIPAT.

    The presentation will include valid examples for using SIPAT in Biologics and API; going from batch production on a single unit operation to complete batch production lines, including continuous manufacturing.

    Pharmaceutical and life science companies may now gather in-depth process understanding, release products in real time and further develop processes based on “Quality by Design” (QbD) principles and manufacture “right-first-time.”

    THIS PROGRAM IS INTENDED FOR

    Professionals from pharmaceutical and life science companies with responsibilities and interests in the following areas:

    • QbD/PAT Development and Implementation
    • Validation
    • Compliance
    • Process Engineering Quality Assurance (QA)
    • Quality Control (QC)
    • Regulatory Affairs
    • Research & Development
    ABOUT OUR SPEAKERS

    Jan Verelst, M.Sc. Chemical Engineering, International Business Development Manager for Life Sciences, Siemens   


    Jan Verelst, M.Sc, has over 20 years of experience in the world of Industrial IT solutions such as Chromatography Data Systems (CDS), Laboratory Information Management Systems (LIMS), Product Lifecycle Management (PLM) and Process Analytical Technology (PAT).

    Mr. Verelst has a Masters Degree in Chemical Engineering from the Catholic University of Leuven (Belgium) and has had the opportunity to do business with different multinational companies in various sectors by finding the right IT-solution offering added value to the customer. Currently he holds the position of International Business Development Manager for Life Sciences with a strong focus on SIPAT, the PAT data management solution of Siemens.

    Dr. Kjell Francois, Ph.D., Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT   


    Kjell Francois is Sr. SIPAT consultant and Business Area Manager at Siemens IS IT based in Ninove, near Brussels (Belgium).

    Mr, Francois has a masters degree in Bio Engineering and a Ph.D. in Applied Biological Sciences from the University of Ghent. He wrote several publications in international peer reviewed journals and books in the field of predictive microbiology in foods, next to participations in several international symposia.

    At Siemens, Mr. Francois worked for some years as project leader in LIMS (Laboratory Information Management Systems) projects before joining the SIPAT development and project team. He was Project leader of the first SIPAT project, being the PAREL project at the NVI. (Dutch Vaccine Institute) and lead engineer & project manager of PAT projects for Wyeth Medica Ireland, Gedeon Richter, Roche, TEVA and Grunenthal. He contributed in several additional PAT/QBD projects for customers like GSK, Ferring and Schering-Plough. Mr. Francois has been leading the Siemens PAT projects team since 2010.

    OUR XTALKS PARTNER FOR THIS EVENT

    Healthy processes with Siemens

    The pharmaceutical and life science industry faces the challenges of a dynamic market environment. Siemens offers the industry support in the form of its experience, expertise and a comprehensive performance spectrum. Classical process analytics and instrumentation, process control systems, automation technology, software solutions, energy management and a global servicing network provide the basis for improved product quality, higher productivity and drug supply chain security.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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