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The shortest course to quality assurance

Computerized systems used in GxP environments have to meet regulatory demands. Training courses run by The Swedish Academy of Pharmaceutical Sciences aim to help participants understand not only how to carry out quality assurance of computerized systems, but how to do so efficiently. Thatís why they use consultants from PlantVision as course tutors.

Whether in research and development, clinical studies, manufacturing, or distribution, computerized systems support many vital functions in every pharmaceutical company. Those computerized systems used within a GxP environment require quality assurance to show they meet regulatory demands.

In most cases, it is possible to achieve substantial cost savings by embracing regulations rather than trying to work around them. PlantVision has shown this time and again in projects carried out for its customers. That’s why The Swedish Academy of Pharmaceutical Sciences chooses to use PlantVision consultants as tutors for courses covering regulations and guidelines, including how to apply and fulfill them in practice.

 

“The strength of the training course is providing so much valuable and concise information in such a short time. The training covers highly relevant areas and the tutor was very competent. Very well-reasoned and structured lecture.”
Participant evaluation of training course at The Swedish Academy of Pharmaceutical Sciences, March 2013
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Training courses provide a solid understanding of regulatory demands for computerized systems, including, effective quality assurance based on risk and scalability, cooperation between customer and vendor, and maintenance of computerized systems.

A thorough understanding of applicable regulations helps to simplify working procedures and eliminate unnecessary activities. This is true whether it relates to system selection, system design and development, system implementation, validation, or maintenance. This same approach can be applied across many areas, from QA/QC, regulatory affairs, and validation, to R&D, distribution and IT.

 

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