Cloud computing and e-archiving of electronic GMP data

Online seminar on January 19th, 2021 with Dr. Arno Terhechte (District Government Münster) and Dr. Dmitrij Lisak (Thescon)

 

With the upcoming digitization in the pharmaceutical industry, the trend towards outsourcing computerized systems keeps  increasing.

Cloud service models seem to be a suitable solution. The handling of GMP / GxP data is regulated by law. Balancing this in a regulated company is a challenge.

The Online Seminar ‘Cloud computing and electronic eArchiving GMP data’ on 19th January 2021 provides best practice approaches.

Dr. Arno Terhechte from the Münster district government responds to the vote of the ZLG (central office of the federal states for health protection for drugs and medical products). In its vote V1100202, the ZLG indicated requirements for the storage of electronic data with regard to the new technological possibilities. Find out the current perspective from an official point of view in the online seminar.

Dr. Dmitrij Lisak from Thescon teaches you the possibilities and regulatory challenges through the use of cloud computing solutions in the regulated GxP environment. Relevant questions from everyday business will be answered:

  • What types of cloud computing exist: IaaS, PaaS, SaaS, XaaS?
  • Which regulatory requirements need to be observed?
  • What risks do cloud solutions entail and how can they be managed?
  • How is the compliance of the systems to be ensured?
  • Validation and qualification of cloud services?
  • How are cloud services validated and qualified?

Further information about the online seminar as well as registrations can be found on the PTS Training Service website here.

 

We look forward to your participation!

Your Thescon team.

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