2024-02-27 2024-02-27 , online online, 1,490 € zzgl. MwSt. Dr. Andreas Jabs https://www.forum-institut.de/seminar/24042473-it-validation-in-gxp/referenten/24/24_04/24042473-online-training-pharma-itvalidation-in-gxp_jabs-andreas.jpg IT validation in GxP

Are you looking for comprehensive expertise to prepare your company's IT for external controls in a compliance-compliant manner with regard to validation processes? On the other hand, do you want to organise the corresponding workflows as efficiently as possible? Get the tools you need to successfully implement your validation projects in our seminar!

Topics
  • IT systems between compliance and economic viability
  • Interfaces GMP/GDP/GCP: Legal considerations
  • GAMP ®: Concept, life cycle, data integrity etc.
  • Efficient organisation of validation projects
  • Cloud computing in the GMP environment
  • Practical workshop


Who should attend
The maintenance of GxP-relevant IT systems and the associated sustainable data and quality assurance are part of your daily tasks or will be in the near future? Are you focussing on validation projects?
The seminar will provide you with comprehensive expertise to ensure that your company IT is set up to comply with external audits/inspections and to organise processes efficiently.
Aims and objectives
The validation of GxP-relevant computerised systems is regularly checked for compliance as part of external controls.
This is contrasted with the economic efficiency of validation projects.
    • As part of this seminar, you will learn/receive, among other things
      • about all relevant aspects of the GAMP 5® validation guideline.
      • how to correctly estimate the costs incurred by validation projects.
      • how to fulfil regulatory requirements for the quality assurance of electronic systems.
      • an update on cloud computing in the GMP environment.

      Furthermore you will apply the theoretical knowledge directly during the practical workshop and thus develop a guideline for your own daily business.
Your benefit

After having attended the seminar, you will

  • be able to organise your validation processes confidently, target orientated and efficiently.
  • be familiar with interface and lifecycle management.
  • have received an update on the topics of data integrity and cloud computing.
  • be optimally prepared for future external audits and inspections.

Online course pharma - ITvalidation in GxP

IT validation in GxP

- Online training -

Benefits
  • Make your company IT compliant
  • Avoid typical mistakes in future external controls
  • Practical workshop: Apply theoretical knowledge directly
  • Officially certified according to ISO 9001 + 21001

Webcode 24042473

Jetzt buchen

JETZT Buchen

Referent


Alles auf einen Blick

Termin

22-23/04/2024

22-23/04/2024

Zeitraum

Day I: 01:00 pm - 05:00 pm - online training
Day II: 09:00 am - 04:00 pm - online training
You may dial in 30 minutes before the training starts

Day I: 01:00 pm - 05:00 pm - online training
Day II: 09:00 am - 04:00 pm - online training
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Are you looking for comprehensive expertise to prepare your company's IT for external controls in a compliance-compliant manner with regard to validation processes? On the other hand, do you want to organise the corresponding workflows as efficiently as possible? Get the tools you need to successfully implement your validation projects in our seminar!

Topics

  • IT systems between compliance and economic viability
  • Interfaces GMP/GDP/GCP: Legal considerations
  • GAMP ®: Concept, life cycle, data integrity etc.
  • Efficient organisation of validation projects
  • Cloud computing in the GMP environment
  • Practical workshop


Who should attend
The maintenance of GxP-relevant IT systems and the associated sustainable data and quality assurance are part of your daily tasks or will be in the near future? Are you focussing on validation projects?
The seminar will provide you with comprehensive expertise to ensure that your company IT is set up to comply with external audits/inspections and to organise processes efficiently.

Aims and objectives

The validation of GxP-relevant computerised systems is regularly checked for compliance as part of external controls.
This is contrasted with the economic efficiency of validation projects.

    • As part of this seminar, you will learn/receive, among other things
      • about all relevant aspects of the GAMP 5® validation guideline.
      • how to correctly estimate the costs incurred by validation projects.
      • how to fulfil regulatory requirements for the quality assurance of electronic systems.
      • an update on cloud computing in the GMP environment.

      Furthermore you will apply the theoretical knowledge directly during the practical workshop and thus develop a guideline for your own daily business.

Your benefit

After having attended the seminar, you will

  • be able to organise your validation processes confidently, target orientated and efficiently.
  • be familiar with interface and lifecycle management.
  • have received an update on the topics of data integrity and cloud computing.
  • be optimally prepared for future external audits and inspections.

Detailed programme

Day I: 01:00 pm - 05:00 pm - online training
Day II: 09:00 am - 04:00 pm - online training
You may dial in 30 minutes before the training starts

13:00 Welcome, introduction, expectations


13:15

IT systems between compliance and economic viability
  • Validation as a form of quality assurance
  • Regulations at a glance
  • Electronic signatures in the GxP environment

14:15

GAMP 5®: Efficient validation
  • Concept of the GAMP® risk-based life cycle
  • Agile development methods - risks and side effects
  • From project start to decommissioning: Processes along the life cycle
  • Data integrity at a glance

15:30 Coffee break


15:45

Projects in the GxP environment
  • Costs under control? Planning, organisation and controlling
  • Designing validation projects efficiently: Challenges for processes, persons and technology

16:45 Wrap-up und Q&As


17:00 End of Seminar day I


09:00 Recap and open questions


09:15

Cloud computing in the GMP environment
  • Qualification of cloud: Is it even possible?
  • Validation of applications in the cloud
  • With SharePoint online into the cloud: Practical examples

10:15 Coffee break


10:30

Workshop
In small groups, you will apply what you have learned to one or different example scenarios. The speaker will be available throughout the workshop for questions, discussions and tips, so that an exchange and thus "learning effect" is possible during the workshop.

12:00 Lunch break


13:00 Recap and outstanding questions


15:45 Recap and outstanding questions


16:00 End of the seminar


Zusatzinformationen

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

Overall score of all evaluations in 2023

Five stars on Trustpilot = Excellent

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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