Christian Reinfelder CEO Experts Institut

MBA Business Consulting

Jessica Siefert

CEO

VITA

Experience:

  • 10 years of experience in management consulting

Expertise:

  • Deviation / change control and CAPA management
  • Optimization of the QM system
  • Supplier management
  • Internal and external audits
  • Data integrity
  • Risk management
  • Regulations / Guidelines
  • Reporting / Evaluations / SOP
  • Training for e.g. data integrity, HACCP, GxP

Passion:

  • Digitalization and sustainability
Computergestützte Systeme
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Computerized systems (CS)

CS are becoming increasingly important, especially in the pharmaceutical industry, in order to meet the increasing demands on production. At the same time, their use must not compromise patient safety. This brings with it increasing challenges…
Künstliche Intelligenz

Artificial intelligence (AI) in consulting

How artificial intelligence is revolutionizing management consulting: Insights into a future where consultants and AI, go hand in hand AI until 2030 In the rapidly evolving business world, companies face the challenge of keeping up…
Lieferantenqualifizierung
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Supplier qualification for pharmaceutical manufacturers

Blog post: Field report by an EI consultant from a supplier qualification project for pharmaceutical manufacturers In the period from 2019 to 2022, I was involved in a project for the supplier qualification of drug manufacturers and active…
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GMP AND DIGITALIZATION: SOME BASIC THOUGHTS

It is almost 8.00 am, we are standing on front of a building which houses an officially GMP-accredited contract laboratory service. Our task for today: carry out a full blown GMP-audit on the contract lab. On the inside I am a bit excited,…

Shaping the future: AI as the key to progressive corporate governance

Artificial intelligence (AI) is more than just a buzzword from the world of science fiction and robotics - it is a technology that is deeply integrated into our everyday lives. As a dynamic and progressive field, AI aims to develop systems that are capable of performing tasks previously reserved for the human mind.

Annex 1 – Revolution in GMP heaven?

a document that is awaited with more excitement than ever before in the history of GMP regulations. One reason for this is that Annex 1 has now been available as a draft for more than 4 years and its publication has been repeatedly delayed for various reasons. According to current information, the publication is now scheduled for September 2022.

EUDRALEX Vol. 4 Part IV: One for all?

Advanced therapy medicinal products (ATMPs) are at the forefront of regulatory developments, including good manufacturing practice requirements. A still very young ATMP GMP guide is going down paths that have not yet existed in the GMP universe.

The new ANNEX 1 02/2020

One of the significant revisions in the draft of the new Annex 1 is the change in the limitation of the bacterial count in cleanroom class "A". Whereas the previous requirement was that a maximum value of "< 1" was permitted in the core zone of aseptic production, the limit is now set to "no growth", i.e. "0" CFU/sampling.

GMP reagent management: Many unspoken rules?

So inconspicuous and yet so important, especially from today's perspective: Section 6.19 of Chapter 6 of the EU GMP guidelines once again significantly increased the effort required to carry out analytical tests. 6.19 Special attention should…
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